Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-19 @ 2:55 PM
Study NCT ID:
NCT03036293
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529609', 'term': 'tenoten'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PutilovskiyMA@materiamedica.ru', 'phone': '+74952761571', 'title': 'Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director', 'phoneExt': '302', 'organization': 'Materia Medica Holding'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the study (12 weeks).', 'description': 'Adverse/Serious adverse events were registered in patients of the Safety population (n=390).', 'eventGroups': [{'id': 'EG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 8, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 12, 'seriousNumAtRisk': 131, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)\n\nRaw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 17, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Supraventricular tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal vascular disorder', 'notes': 'Retinal angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial vaginosis', 'notes': 'Vaginosis bacterial NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'notes': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye contusion', 'notes': 'Periorbital contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'notes': 'Lumbar pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'notes': 'Cramps in legs (calf)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteochondrosis', 'notes': 'Osteochondrosis of spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Menstruation delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysgeusia', 'notes': 'Taste metallic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'notes': 'Headache NOS, temporal headache, headache unilateral, headache fullness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Occipital neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'notes': 'Daytime sleepiness, sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Mean HAM-A Score at 12 Weeks of Treatment: 1. Group 1 (Tenoten®, 4 Tablets a Day); 2. Group 3 (Tenoten®, 8 Tablets a Day).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '18.81', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '4.32', 'groupId': 'OG001'}, {'value': '17.88', 'spread': '5.42', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '7.26', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '6.40', 'spread': '4.02', 'groupId': 'OG001'}, {'value': '8.48', 'spread': '5.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0055', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.33', 'paramValue': '1.56', 'ciLowerLimit': '0.217', 'ciUpperLimit': '2.91', 'groupDescription': 'Mean score differences (begin-end) were compared', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline score used as covariate'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.33', 'paramValue': '2.56', 'ciLowerLimit': '1.1', 'ciUpperLimit': '3.96', 'estimateComment': 'estimate and CL are backtransformed', 'groupDescription': 'Mean score differences (begin-end) were compared', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline score used as covariate. Yeo-Johnson transformation with λ=1,09 was applied. Statistical inference performed for transformed values.'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.33', 'paramValue': '0.89', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '2.33', 'groupDescription': 'Mean score differences (begin-end) were compared', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Baseline score used as covariate', 'nonInferiorityComment': 'equivalence limits were prespecified as \\[-2.763; 2.763\\]'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Mean HAM-A Score at 4 Weeks of Treatment: 1.1. Group 1 (Tenoten®, 4 Tablets a Day); 1.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '18.81', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '4.32', 'groupId': 'OG001'}, {'value': '17.88', 'spread': '5.42', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '13.73', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '13.31', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '13.85', 'spread': '5.34', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '1.54', 'groupDescription': 'Mean score differences (begin-end) were compared', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline score used as covariate'}, {'pValue': '0.044', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.66', 'groupDescription': 'Mean score differences (begin-end) were compared', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline score used as covariate'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.'}, {'type': 'SECONDARY', 'title': 'The Mean HAM-A Score at 8 Weeks of Treatment: 2.1. Group 1 (Tenoten®, 4 Tablets a Day); 2.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '18.81', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '4.32', 'groupId': 'OG001'}, {'value': '17.88', 'spread': '5.42', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '10.61', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '4.93', 'groupId': 'OG001'}, {'value': '10.81', 'spread': '5.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.78', 'groupDescription': 'Mean score differences (begin-end) were compared', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline score used as covariate'}, {'pValue': '0.027', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.14', 'ciUpperLimit': '2.26', 'groupDescription': 'Mean score differences (begin-end) were compared', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline score used as covariate'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data from groгps placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Had at Least a 50% Improvement in the HAM-A Score: 3.1. Group 1 (Tenoten® 4 Tablets a Day): After 4, 8 and 12 Weeks; 3.2. Group 3 (Tenoten® 8 Tablets a Day): After 4, 8 and 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.065', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.89', 'estimateComment': 'Bigger OR is better', 'groupDescription': 'Common OR of event analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0015', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.22', 'ciUpperLimit': '2.33', 'estimateComment': 'Bigger OR is better', 'groupDescription': 'Common OR of event analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 4 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 8 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 12 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.57', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Week 4 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.25', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Week 8 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Week 12 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4,8,12 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With no Anxiety (HAM-A Score <14) in: 4.1. Group 1 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks; 4.3. Group 3 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.23', 'estimateComment': 'Bigger OR is better', 'groupDescription': 'Common OR of event analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.17', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.79', 'estimateComment': 'Bigger OR is better', 'groupDescription': 'Common OR of event analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 4 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.67', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 8 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.85', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Week 12 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.71', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Week 4 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.29', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Week 8 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Week 12 frequencies comparison', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4,8,12 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total EQ-5D-3L Score at 12 Weeks of Treatment in Patients From: 5.1. Group 1 (Tenoten®, 4 Tablets a Day); 5.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '7.44', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '7.48', 'spread': '1.28', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '5.84', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '6.05', 'spread': '1.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.314', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00002', 'ciLowerLimit': '-0.00002', 'ciUpperLimit': '0.33', 'estimateComment': 'Hodges-Lehmann estimator for location difference provided', 'groupDescription': 'Median changes (begin-end) within groups are compared', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '1', 'estimateComment': 'Hodges-Lehmann estimator for location difference provided', 'groupDescription': 'Median changes (begin-end) within groups are compared', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'European Quality of Life Instrument questionnaire (EQ-5D-3L) is designed for the evaluation of the quality of life.The score ranges between 5-15. Higher values represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.'}, {'type': 'SECONDARY', 'title': 'Total CGI Scores in Patients From: 6.1. Group 1 (Tenoten®, 4 Tablets a Day); 6.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG001', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'OG002', 'title': 'Placebo-2 + Placebo-4', 'description': 'Placebo-2 (2 tablets twice daily) and Placebo-4 (2 tablets 4 times daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.53', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '4.55', 'spread': '2.91', 'groupId': 'OG001'}, {'value': '5.71', 'spread': '3.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00001', 'ciLowerLimit': '-3', 'ciUpperLimit': '-0.00001', 'estimateComment': 'Lower is better', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0056', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00002', 'ciLowerLimit': '-1', 'ciUpperLimit': '-0.00002', 'estimateComment': 'Lower is better', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "Clinical Global Impession (CGI) provides a brief assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. Total range 0-16. Higher values represent a worse outcome", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Raw data from groups placebo-2 and placebo-4 was pooled into combined Placebo group. In accordance with study protocol no dose dependency in placebo effect was assumed. In accordance with study protocol no regiment dependency in placebo effect was assumed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'FG001', 'title': 'Placebo, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nPlacebo: Tablet for oral use.'}, {'id': 'FG002', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'FG003', 'title': 'Placebo, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nPlacebo: Tablet for oral use.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '131'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '130'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenoten, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'BG001', 'title': 'Placebo, 2 Tablets Twice Daily (4 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.\n\nPlacebo: Tablet for oral use.'}, {'id': 'BG002', 'title': 'Tenoten, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nTenoten: Tablet for oral use.'}, {'id': 'BG003', 'title': 'Placebo, 2 Tablets 4 Times Daily (8 Tablets/Day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.\n\nPlacebo: Tablet for oral use.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '32.7', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '7.6', 'groupId': 'BG002'}, {'value': '34.8', 'spread': '8', 'groupId': 'BG003'}, {'value': '33.4', 'spread': '7.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '303', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kazakhstan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '367', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HAM-A scale baseline score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '18.84', 'spread': '5.81', 'groupId': 'BG000'}, {'value': '17.69', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '18.53', 'spread': '4.32', 'groupId': 'BG002'}, {'value': '18.2', 'spread': '6.02', 'groupId': 'BG003'}, {'value': '18.43', 'spread': '5.32', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular, sensory, cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'EQ-5D-3L baseline score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.44', 'spread': '1.44', 'groupId': 'BG000'}, {'value': '7.51', 'spread': '1.13', 'groupId': 'BG001'}, {'value': '7.42', 'spread': '1.05', 'groupId': 'BG002'}, {'value': '7.47', 'spread': '1.45', 'groupId': 'BG003'}, {'value': '7.45', 'spread': '1.19', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'EQ-5D-3L questionnaire (European Quality of Life Instrument). Raw score range 5-15. The lower the better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety and Depression Scale (HADS)-Anxiety', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '13.52', 'spread': '1.79', 'groupId': 'BG000'}, {'value': '13.01', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '13.49', 'spread': '1.79', 'groupId': 'BG002'}, {'value': '13.46', 'spread': '1.99', 'groupId': 'BG003'}, {'value': '13.41', 'spread': '1.79', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Hospital Anxiety and Depression Scale - Anxiety subscale. Total score 0-21. The lower the better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-19', 'size': 539704, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-23T05:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2017-01-26', 'resultsFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-03', 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Mean HAM-A Score at 12 Weeks of Treatment: 1. Group 1 (Tenoten®, 4 Tablets a Day); 2. Group 3 (Tenoten®, 8 Tablets a Day).', 'timeFrame': '12 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Mean HAM-A Score at 4 Weeks of Treatment: 1.1. Group 1 (Tenoten®, 4 Tablets a Day); 1.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'timeFrame': '4 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome'}, {'measure': 'The Mean HAM-A Score at 8 Weeks of Treatment: 2.1. Group 1 (Tenoten®, 4 Tablets a Day); 2.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'timeFrame': '8 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome'}, {'measure': 'Percentage of Patients Had at Least a 50% Improvement in the HAM-A Score: 3.1. Group 1 (Tenoten® 4 Tablets a Day): After 4, 8 and 12 Weeks; 3.2. Group 3 (Tenoten® 8 Tablets a Day): After 4, 8 and 12 Weeks.', 'timeFrame': '4,8,12 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome'}, {'measure': 'Percentage of Patients With no Anxiety (HAM-A Score <14) in: 4.1. Group 1 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks; 4.3. Group 3 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks.', 'timeFrame': '4,8,12 weeks', 'description': 'The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview.\n\nAnxiety scoring:\n\n≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder;\n\n≥25 - severe anxiety.\n\nHigher values represent a worse outcome'}, {'measure': 'Change From Baseline in the Total EQ-5D-3L Score at 12 Weeks of Treatment in Patients From: 5.1. Group 1 (Tenoten®, 4 Tablets a Day); 5.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'timeFrame': '12 weeks', 'description': 'European Quality of Life Instrument questionnaire (EQ-5D-3L) is designed for the evaluation of the quality of life.The score ranges between 5-15. Higher values represent a worse outcome.'}, {'measure': 'Total CGI Scores in Patients From: 6.1. Group 1 (Tenoten®, 4 Tablets a Day); 6.2. Group 3 (Tenoten®, 8 Tablets a Day).', 'timeFrame': '12 weeks', 'description': "Clinical Global Impession (CGI) provides a brief assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. Total range 0-16. Higher values represent a worse outcome"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '34930979', 'type': 'DERIVED', 'citation': 'Parfenov VA, Kamchatnov PR, Khasanova DR, Bogdanov EI, Lokshtanova TM, Amelin AV, Maslova NN, Pizova NV, Belskaya GN, Barantsevich ER, Duchshanova GA, Kamenova SU, Kolokolov OV, Glazunov AB. The randomized clinical trial results of the anxiety treatment in patients with somatoform dysfunction and neurotic disorders. Sci Rep. 2021 Dec 20;11(1):24282. doi: 10.1038/s41598-021-03727-5.', 'retractions': [{'pmid': '36104393', 'source': 'Sci Rep. 2022 Sep 14;12(1):15416'}]}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are:\n\n* To further examine the efficacy and safety of Tenoten® in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders.\n* To compare the efficacy of two dosing regimens of Tenoten® (4 tablets daily vs.8 tablets daily, both for 12 weeks) in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders.', 'detailedDescription': 'Design: an international, a multicenter, double-blind, randomized, parallel group placebo-controlled trial to evaluate efficacy and safety of study treatment.\n\nThe study will enroll outpatient subjects of both genders aged 18-45 years with verified diagnoses of somatoform, stress-related and other neurotic disorders (F43, F45, F48) and signs of clinically relevant anxiety according to The Hospital Anxiety and Depression scale (HADS).\n\nAfter signing the informed consent form to participate in the clinical study the subject will be interviewed (complaints, medical history, concomitant therapy) and objective examination will be performed; the subject will fill HADS scale. The severity of anxiety at screening should be ≥ 11 according to HADS. If the subject meets inclusion criteria and has no exclusion criteria he/she will be enrolled into the study. The investigator will determine the severity of anxiety using НАМ-А scale; the subject will fill EQ-5D-3L questionnaire. At Visit 1 (Day 1) the subject will be randomized into one of the treatment groups:\n\n* Group 1: Tenoten® at 2 tablets twice daily (4 tablets/day);\n* Group 2: Placebo at 2 tablets twice daily (4 tablets/day);\n* Group 3: Tenoten® at 2 tablets 4 daily (8 tablets/day).\n* Group 4: Placebo at 2 tablets 4 daily (8 tablets/day). The first dose should be administered at Visit 1 after the visit procedures are completed. Further administration of the study product will be made according to the dosing scheme. The subject will administer the study product and will be followed for 12 weeks during which additional three visits will be made. At Visit 2 (Week 4), Visit 3 (Week 8) and Visit 4 (Week 12) the physician will record patients\' complaints and physical examination data, fill HAM-A scale, check the study and concomitant therapy, assess treatment safety and patient compliance with the study treatment. At the final Visit 4 the subject will fill EQ-5D-3L questionnaire and the investigator will fill the Clinical Global Impression Scale Efficacy Index (CGI-EI).\n\nSubjects will be allowed to take symptomatic therapy and medications for their co-morbidities during the study, except for the medicines listed in "Prohibited therapy".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of both sexes aged 18-45 years (inclusive).\n2. Patients diagnosed with somatoform, stress-related, and other neurotic disorders (F43, F45, and F48), in accordance with the ICD-10 criteria.\n3. A moderate and severe anxiety (HADS score ≥ 11) documented at screening.\n4. Patients providing signed Informed Consent form for participation in the clinical trial.\n5. Patients of reproductive age (of both sexes) using contraceptives and contraceptive methods during the study and for 30 days after the end of participation in the trial.\n\nExclusion Criteria:\n\n1. Moderate and severe depression symptoms recorded at screening (HADS score ≥ 11).\n2. Organic, including symptomatic, mental disorders (F00-09).\n3. Mental and behavioural disorders due to psychoactive substance use (F10-19).\n4. Schizophrenia, schizotypal and delusional disorders (F20-29).\n5. Mood \\[affective\\] disorders(F30-39).\n6. Phobic (F40) and other anxiety disorders (F41), obsessive-compulsive disorder (F42), dissociative \\[conversion\\] disorders (F44), depersonalization-derealization syndrome (F48.1).\n7. Behavioral syndromes associated with physiological disturbances and physical factors (F50-59).\n8. Disorders of adult personality and behavior (F60-69).\n9. Intellectual disabilities (F70-79).\n10. Inflammatory and traumatic brain injuries with permanent neurological deficit.\n11. Prior diagnosis of a class III or IV cardiovascular disease (according to the New York Heart Association, 1964)\n12. Malignant neoplasms/suspected malignant neoplasms.\n13. An allergy/intolerance to any of the components of medications used in the treatment.\n14. Malabsorption syndrome (including hereditary or acquired lactase or other disaccharidase deficiency) and galactosemia.\n15. Any conditions that, from investigator\'s point of view, may affect the patient\'s ability to participate in the trial.\n16. Hospitalizations or surgeries scheduled for any date during the participation in the study.\n17. Patients who, from investigator\'s point of view, will fail to comply with the observation requirements of the trial or with the dosing regimen of the study drugs.\n18. Use of drugs listed in "Prohibited therapy" within a month prior to enrollment.\n19. Drug addiction, alcohol use in the amount over 2 units of alcohol a day.\n20. Pregnant or breast-feeding women.\n21. Participation in other clinical trials within 3 month prior to the enrollment in this study.\n22. Patients are related to the research personnel of the investigative site who are directly involved in the trial, or patients who are the immediate family member of the researcher. The \'immediate family member\' includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.\n23. Patients working for OOO "NPF "MATERIA MEDICA HOLDING", i.e. the company\'s employee, temporary contract worker, or appointed official responsible for carrying out the research (or the immediate relative).'}, 'identificationModule': {'nctId': 'NCT03036293', 'briefTitle': 'Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Materia Medica Holding'}, 'officialTitle': 'International Multicenter, Double-blind, Randomized Placebo-controlled Phase IV Clinical Trial of Different Dosing Regimens of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders', 'orgStudyIdInfo': {'id': 'MMH-TN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenoten, 2 tablets twice daily (4 tablets/day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.', 'interventionNames': ['Drug: Tenoten']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, 2 tablets twice daily (4 tablets/day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tenoten, 2 tablets 4 times daily (8 tablets/day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.', 'interventionNames': ['Drug: Tenoten']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, 2 tablets 4 times daily (8 tablets/day)', 'description': 'Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tenoten', 'type': 'DRUG', 'description': 'Tablet for oral use.', 'armGroupLabels': ['Tenoten, 2 tablets 4 times daily (8 tablets/day)', 'Tenoten, 2 tablets twice daily (4 tablets/day)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet for oral use.', 'armGroupLabels': ['Placebo, 2 tablets 4 times daily (8 tablets/day)', 'Placebo, 2 tablets twice daily (4 tablets/day)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Kazakh National Medical University named after S.D. 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Pirogov Clinical Hospital №1"', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410012', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Saratov State Medical University named after V. I. Razumovsky', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '214018', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'The State Budget Educational institution of High Professional Training Smolensk State Medical University of Ministry of Health Care of the Russian Federation, Smolensk regional clinical hospital', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '600023', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '400131', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd State Medical University', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '150030', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150030', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'The State Health Care Institution Yaroslavl region "Clinical Hospital №8', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Vladimir Parfenov, DrMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Materia Medica Holding', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}