Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT01793935
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030693', 'term': 'Ashwagandha'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chengappakn@upmc.edu', 'phone': '412-246-5006', 'title': 'Dr. K.N. Roy Chengappa - PI', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were evaluated during the study period (12 weeks)', 'description': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes', 'eventGroups': [{'id': 'EG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 24, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 20, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'loose stools/diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspepsia (heartburn)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperactive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening of psychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue/lathargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive and Negative Syndrome Scale (PANSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'PANSS Positive Baseline', 'categories': [{'measurements': [{'value': '19.58', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '19.97', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'PANSS Positive at 12 weeks', 'categories': [{'measurements': [{'value': '14.39', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '15.33', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'PANSS Negative Baselin', 'categories': [{'measurements': [{'value': '16.52', 'spread': '4.52', 'groupId': 'OG000'}, {'value': '17.27', 'spread': '5.25', 'groupId': 'OG001'}]}]}, {'title': 'PANSS Negative at 12 weeks', 'categories': [{'measurements': [{'value': '12.97', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '15.88', 'spread': '5.75', 'groupId': 'OG001'}]}]}, {'title': 'PANSS General Baseline', 'categories': [{'measurements': [{'value': '33.79', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '33.24', 'spread': '5.27', 'groupId': 'OG001'}]}]}, {'title': 'PANSS General at 12 weeks', 'categories': [{'measurements': [{'value': '26.55', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '30.27', 'spread': '7.45', 'groupId': 'OG001'}]}]}, {'title': 'PANSS Total at Baseline', 'categories': [{'measurements': [{'value': '69.88', 'spread': '8.00', 'groupId': 'OG000'}, {'value': '69.48', 'spread': '8.45', 'groupId': 'OG001'}]}]}, {'title': 'PANSS total at 12 weeks', 'categories': [{'measurements': [{'value': '53.91', 'spread': '11.40', 'groupId': 'OG000'}, {'value': '61.48', 'spread': '14.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms.\n\nPANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.\n\nPANSS Negative subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.\n\nGeneral Psychopathology subscale consists of 16 items - (minimum score = 16, maximum score = 112) - Higher values represent a worse outcome.\n\nPANSS Total Score - The 3 subscales scores are summed to compute a PANSS Total score. The minimum PANSS total score = 30, maximum = 210 - Higher values represent a worse outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'SECONDARY', 'title': 'Perceived Stress Scale (PSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'PSS score at Baseline', 'categories': [{'measurements': [{'value': '22.48', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '20.55', 'spread': '6.68', 'groupId': 'OG001'}]}]}, {'title': 'PSS score at 12 weeks', 'categories': [{'measurements': [{'value': '14.67', 'spread': '5.87', 'groupId': 'OG000'}, {'value': '18.09', 'spread': '6.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of treatment', 'description': "The Perceived Stress Scale (PSS) was developed to measure the degree to which situations in one's life are appraised as stressful.\n\nPerceived Stress Scale Scoring Each item is rated on a 5-point scale ranging from never (0) to very often (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.\n\nPSS-10 scores are obtained by reversing the scores on the four positive items:\n\nFor example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Total score can range from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress,", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression Scale (CGI-S) - Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'CGI Severity score at baseline', 'categories': [{'measurements': [{'value': '4.06', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'CGI Severity score at 12 weeks', 'categories': [{'measurements': [{'value': '3.88', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 0 = not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients - The higher the score the worse outcome", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': "The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: Possible ratings are: 1= Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5= Minimally worse, 6= Much worse, 7=Very much worse.\n\nThe higher the score the worse outcome", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'SECONDARY', 'title': 'Immune Marker IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'data cannot be summarized- IL-2 levels undetectable', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'data cannot be summarized- IL-2 levels undetectable', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Changes in immune marker IL-2 will be assessed in response to study medication.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IL-2 levels undetectable.'}, {'type': 'SECONDARY', 'title': 'Immune Marker IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'data cannot be summarized- IL-4 levels undetectable', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'data cannot be summarized- IL-4 levels undetectable', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and12 weeks or end of study', 'description': 'Changes in immune marker IL-4 will be assessed in response to study medication.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data cannot be summarized- IL-4 levels undetectable'}, {'type': 'SECONDARY', 'title': 'Immune Marker IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'IL6 level at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.37', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'IL 6 level at end of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.40', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '2.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline in Immune markers at 12 weeks or end of study', 'description': 'Changes in immune marker IL-6 will be assessed in response to study medication.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "number analyzed" differs from the "overall number of participants analyzed" because not all participants had baseline and end of treatment values for IL-6.'}, {'type': 'SECONDARY', 'title': 'Immune Marker IFN-Y (Gamma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'data cannot be summarized IFN-Y (gamma) levels undetectable', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'data cannot be summarized IFN-Y (gamma) levels undetectable', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Changes in immune marker IFN-Y (gamma) will be assessed in response to study medication.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data cannot be summarized IFN-Y (gamma) levels undetectable'}, {'type': 'SECONDARY', 'title': 'Immune Marker Hs-CRP (High Sensitivity C Reactive Protein)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'Pre Rx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.57', 'spread': '8.57', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '6.90', 'groupId': 'OG001'}]}]}, {'title': 'End of Rx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.49', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '7.82', 'spread': '8.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Changes in immune marker hs-CRP (high sensitivity C Reactive Protein) will be assessed in response to study medication.\n\nhsCRP - mg/L', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "number analyzed" differs from the "overall number of participants analyzed" because not all participants had baseline and end of treatment values for hs-CRP.'}, {'type': 'SECONDARY', 'title': 'Immune Marker S-100B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'S100B pre Rx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.36', 'spread': '89.92', 'groupId': 'OG000'}, {'value': '34.95', 'spread': '56.12', 'groupId': 'OG001'}]}]}, {'title': 'S100B end of Rx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.38', 'spread': '79.44', 'groupId': 'OG000'}, {'value': '62.49', 'spread': '173.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of treatment', 'description': 'Changes in immune marker S-100B will be assessed in response to study medication.\n\nElisa\n\n* Sensitivity 2.7 picogm/ml\n* Range 2.7 to 2000 picogm/ml', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "number analyzed" differs from the "overall number of participants analyzed" because not all participants had baseline and end of treatment values for S-100B.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs - Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'Body Weight at baseline', 'categories': [{'measurements': [{'value': '194.61', 'spread': '49.57', 'groupId': 'OG000'}, {'value': '191.33', 'spread': '41.29', 'groupId': 'OG001'}]}]}, {'title': 'Body Weight at end of Rx', 'categories': [{'measurements': [{'value': '197.00', 'spread': '51.94', 'groupId': 'OG000'}, {'value': '193.06', 'spread': '41.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in weight will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study', 'unitOfMeasure': 'lbs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs - Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'BMI at baseline', 'categories': [{'measurements': [{'value': '30.00', 'spread': '7.56', 'groupId': 'OG000'}, {'value': '30.36', 'spread': '6.35', 'groupId': 'OG001'}]}]}, {'title': 'BMI at end of treatment', 'categories': [{'measurements': [{'value': '30.33', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '30.56', 'spread': '6.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in BMI will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs - Blood Pressure Systolic and Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'Systolic BP at baseline', 'categories': [{'measurements': [{'value': '124.67', 'spread': '10.53', 'groupId': 'OG000'}, {'value': '123.42', 'spread': '15.32', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP at end of treatment', 'categories': [{'measurements': [{'value': '123.36', 'spread': '9.30', 'groupId': 'OG000'}, {'value': '118.39', 'spread': '23.19', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP at baseline', 'categories': [{'measurements': [{'value': '79.15', 'spread': '7.95', 'groupId': 'OG000'}, {'value': '76.52', 'spread': '11.52', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP at end of treatment', 'categories': [{'measurements': [{'value': '79.06', 'spread': '7.31', 'groupId': 'OG000'}, {'value': '75.55', 'spread': '13.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in BP will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.', 'unitOfMeasure': 'mm/Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs - Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'Pulse at baseline', 'categories': [{'measurements': [{'value': '76.18', 'spread': '13.38', 'groupId': 'OG000'}, {'value': '74.91', 'spread': '11.75', 'groupId': 'OG001'}]}]}, {'title': 'Pulse at end of treatment', 'categories': [{'measurements': [{'value': '75.42', 'spread': '14.64', 'groupId': 'OG000'}, {'value': '76.42', 'spread': '9.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in Pulse will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vital Signs - Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'classes': [{'title': 'Temperature at baseline', 'categories': [{'measurements': [{'value': '97.38', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '97.36', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Temperature at end of treatment', 'categories': [{'measurements': [{'value': '97.37', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '97.31', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in Temperature will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.', 'unitOfMeasure': 'degrees F', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Laboratory Analytes', 'timeFrame': 'Change from Baseline in Laboratory Analytes at 12 weeks or end of study', 'description': 'Changes in laboratory analytes will be classified as "normal" or "abnormal" (example: white blood cell counts)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient did not take study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera\n\nSensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.18', 'spread': '12.90', 'groupId': 'BG000'}, {'value': '47.38', 'spread': '11.37', 'groupId': 'BG001'}, {'value': '46.28', 'spread': '12.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis Schizophrenia or Schizoaffective', 'classes': [{'categories': [{'title': 'Diagnosis Schizophrenia', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Diagnosis Schizoaffective', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of lifetime psychiatric hospitalizations', 'classes': [{'categories': [{'measurements': [{'value': '7.71', 'spread': '6.45', 'groupId': 'BG000'}, {'value': '7.76', 'spread': '6.90', 'groupId': 'BG001'}, {'value': '7.74', 'spread': '6.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'psychiatric hospitalizations', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at onset of 1st episode', 'classes': [{'categories': [{'measurements': [{'value': '24.32', 'spread': '10.89', 'groupId': 'BG000'}, {'value': '24.00', 'spread': '7.67', 'groupId': 'BG001'}, {'value': '24.16', 'spread': '9.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current Smokers', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '34 subjects were randomized in each group but 1 subject in each group never came to pick up study medication and therefore are not included in the Overall number of participants analyzed in each outcome measure. They did not contribute any data to the intention to treat group.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2013-02-12', 'resultsFirstSubmitDate': '2017-07-07', 'studyFirstSubmitQcDate': '2013-02-15', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-20', 'studyFirstPostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vital Signs - Weight', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in weight will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study'}, {'measure': 'Vital Signs - Body Mass Index', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in BMI will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.'}, {'measure': 'Vital Signs - Blood Pressure Systolic and Diastolic', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in BP will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.'}, {'measure': 'Vital Signs - Pulse', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in Pulse will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.'}, {'measure': 'Vital Signs - Temperature', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Clinically significant changes in Temperature will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.'}, {'measure': 'Laboratory Analytes', 'timeFrame': 'Change from Baseline in Laboratory Analytes at 12 weeks or end of study', 'description': 'Changes in laboratory analytes will be classified as "normal" or "abnormal" (example: white blood cell counts)'}], 'primaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms.\n\nPANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.\n\nPANSS Negative subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.\n\nGeneral Psychopathology subscale consists of 16 items - (minimum score = 16, maximum score = 112) - Higher values represent a worse outcome.\n\nPANSS Total Score - The 3 subscales scores are summed to compute a PANSS Total score. The minimum PANSS total score = 30, maximum = 210 - Higher values represent a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'Baseline and 12 weeks or end of treatment', 'description': "The Perceived Stress Scale (PSS) was developed to measure the degree to which situations in one's life are appraised as stressful.\n\nPerceived Stress Scale Scoring Each item is rated on a 5-point scale ranging from never (0) to very often (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.\n\nPSS-10 scores are obtained by reversing the scores on the four positive items:\n\nFor example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Total score can range from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress,"}, {'measure': 'Clinical Global Impression Scale (CGI-S) - Severity', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': "The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 0 = not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients - The higher the score the worse outcome"}, {'measure': 'Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale', 'timeFrame': '12 weeks', 'description': "The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: Possible ratings are: 1= Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5= Minimally worse, 6= Much worse, 7=Very much worse.\n\nThe higher the score the worse outcome"}, {'measure': 'Immune Marker IL-2', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Changes in immune marker IL-2 will be assessed in response to study medication.'}, {'measure': 'Immune Marker IL-4', 'timeFrame': 'Baseline and12 weeks or end of study', 'description': 'Changes in immune marker IL-4 will be assessed in response to study medication.'}, {'measure': 'Immune Marker IL-6', 'timeFrame': 'Changes from Baseline in Immune markers at 12 weeks or end of study', 'description': 'Changes in immune marker IL-6 will be assessed in response to study medication.'}, {'measure': 'Immune Marker IFN-Y (Gamma)', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Changes in immune marker IFN-Y (gamma) will be assessed in response to study medication.'}, {'measure': 'Immune Marker Hs-CRP (High Sensitivity C Reactive Protein)', 'timeFrame': 'Baseline and 12 weeks or end of study', 'description': 'Changes in immune marker hs-CRP (high sensitivity C Reactive Protein) will be assessed in response to study medication.\n\nhsCRP - mg/L'}, {'measure': 'Immune Marker S-100B', 'timeFrame': 'Baseline and 12 weeks or end of treatment', 'description': 'Changes in immune marker S-100B will be assessed in response to study medication.\n\nElisa\n\n* Sensitivity 2.7 picogm/ml\n* Range 2.7 to 2000 picogm/ml'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Sensoril', 'Withania Somnifera extract', 'Total/ Positive / Negative Symptoms', 'Stress', 'Inflammation', 'Immunomodulation'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '29995356', 'type': 'DERIVED', 'citation': 'Chengappa KNR, Brar JS, Gannon JM, Schlicht PJ. Adjunctive Use of a Standardized Extract of Withania somnifera (Ashwagandha) to Treat Symptom Exacerbation in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2018 Jul 10;79(5):17m11826. doi: 10.4088/JCP.17m11826.'}]}, 'descriptionModule': {'briefSummary': 'Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or to build resistance to stress or diseases in indigenous medical systems in India for centuries. Modern scientific data for WSE indicate several bioactive molecules (withanolides, withanosides, indosides, withaferin-A, others) with significant immunomodulatory, anti-inflammatory and stress reducing properties.\n\nThis study will examine whether a standardized extract of Withania Somnifera (WSE; Sensoril®) will improve total, positive, negative symptoms, and stress in patients with schizophrenia. The study will examine whether WSE reduces PANSS positive and negative symptoms and stress scores in subjects, and whether these improvements are mediated by changes in inflammatory immune indices. An additional aim will determine if patients receiving WSE will have fewer adjustments to their psychotropic medications that those assigned to placebo. The study will examine whether WSE will re-balance Th1/Th2 ratios (cytokine measures) and mediate a reduction of elevated hs-CRP levels. It is hypothesized that those subjects whose Th1/Th2 ratios normalize will likely have a greater magnitude of clinical improvement versus those subjects whose immune ratios remain unbalanced.\n\nThe proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to antipsychotic medications in approximately 60 or more patients with schizophrenia with an exacerbation of symptoms. If efficacy is affirmed, this low cost extract could be studied further, and used quite readily across low, middle and high income countries.', 'detailedDescription': 'The primary aim is to determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total) and stress scores(PSS total) in persons with schizophrenia?\n\nThe study will also determine whether WSE reduces measures of positive and negative and general symptoms of schizophrenia (PANSS subscale scores)?\n\nAnother primary aim will be to determine if changes in antipsychotic and/or other psychotropic medications (lithium, anticonvulsants, antidepressants, anxiolytic agents or hypnotics) (examples: dosage escalation or reductions or switch or stoppage) will favor the group receiving the standardized Withania somnifera extract versus those receiving placebo. Even though we expect changes in antipsychotic medications to occur when patients experience an exacerbation of psychotic symptoms (or other psychiatric symptoms), we hypothesize that those receiving the standardized Withania somnifera extract will experience fewer medication adjustments then those assigned to placebo.\n\nA secondary aim is to determine whether WSE will rebalance TH1/TH2 ratios (cytokine measures) and mediate a reduction of elevated hs-CRP levels? The study will assess whether those subjects whose TH1/TH2 ratios normalize have a greater magnitude of clinical improvement vs. those subjects whose immune ratios remain unbalanced. Similarly, the study will assess whether reduction of hsCRP levels correlate with improvements in PANSS total and subscale scores or the PSS total scores.\n\nEighty or more patients with DSM IV TR (or if instituted by the study initiation: DSM V) schizophrenia or schizoaffective disorder will be screened and 60 or more eligible patients will be enrolled in a 12 week placebo controlled double blind study. Subjects who have experienced an exacerbation of positive symptoms (delusions, hallucinations, etc). Subjects receiving medications that affect the immune-inflammatory system will be excluded and those receiving antibiotics, antiviral or anti-parasitic medications will be excluded.\n\nBase line laboratory and EKG examination will be carried out to establish eligibility for study participation. In addition specific laboratory analyses of immune markers namely interleukin-2, interferon gamma, interleukin-4, interleukin 6 and high sensitivity C-Reactive Protein will be carried out.\n\nSixty or more patients will be randomly assigned to receive either WSE or matching placebo starting with 1 capsule of 250 mg strength twice a day (total daily dose = 500 mg) for the first week which will be increased to 2 capsules of 250 mg twice daily (total daily dose = 1000 mg) for a total treatment period of 12 weeks. An assessment of psychopathology (PANSS) and stress will be carried out at each scheduled visit. Assessments of safety including vital signs and treatment emergent adverse events will also be carried out at each visit. Immune-inflammatory markers will be re-assessed at the final visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult males or females (≥ 18 years, to 75 years)\n2. DSM IV TR diagnosis of schizophrenia or schizoaffective disorder (If officially instituted by study initiation: DSM V diagnoses will be used).\n3. Ability to provide informed written consent\n4. PANSS total score ≥ 60, positive symptom cluster, (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content with at least 2 items scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme\n5. Current symptom exacerbation ≥ 2 weeks, but ≤ 1 year\n6. Receiving anti-psychotic medications for ≥ 4 weeks\n7. For women of child bearing age, a negative pregnancy test at screening.\n\nExclusion Criteria:\n\n1. Testing positive for illicit substances (marijuana or alcohol use will be assessed on a case by case basis, caffeine and nicotine are excepted)\n2. Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis\n3. Seriously unstable medical illnesses\n4. Pregnant or breast feeding women\n5. Known allergy or history of serious adverse event with WSE\n6. Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)\n7. Currently receiving antibiotics, anti-viral, or anti-parasitic medications\n8. Currently receiving immunosuppressive medications (e.g. corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs).\n9. Currently receiving NSAIDs or Aspirin (\\>81 mg/day) on a daily basis or PRN use \\> 2x/week (in the last 4 weeks).'}, 'identificationModule': {'nctId': 'NCT01793935', 'briefTitle': 'Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Sensoril® (Ashwagandha), an Immunomodulator and Anti-inflammatory Agent for Schizophrenia: A Parallel Group, Randomized Double Blind, and Placebo Controlled Study', 'orgStudyIdInfo': {'id': 'SMRI #: 12T-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensoril®', 'description': 'Sensoril® is a proprietary extract of Withania Somnifera', 'interventionNames': ['Drug: Sensoril®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sensoril®', 'type': 'DRUG', 'otherNames': ['Ashwagandha'], 'description': 'Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera', 'armGroupLabels': ['Sensoril®']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['"Sugar Pill"'], 'description': 'Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute & Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'KN Roy Chengappa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'K.N. Roy Chengappa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'K.N. Roy Chengappa', 'investigatorAffiliation': 'University of Pittsburgh'}}}}