Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-21 @ 10:22 PM
Study NCT ID:
NCT06510257
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2024-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Reconyl for Cough With/Without Sore Throat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cough score', 'timeFrame': 'Day 0, Day 1, Day 2, Day 3', 'description': 'Scoring will be performed and recorded daily in the Subject Diary at time 0, every night time and before the morning dose.\n\nAt the End of Study (last visit) will be assessed by the subject and recorded by the Investigator.\n\nCough score:\n\n• Day time: 0 = No cough; 1= Transient cough occasionally during the daytime; 2 = Frequent cough mildly affecting daily life; 3 = Frequent cough severely affecting daily life.\n\n• Night time: 0 = No cough; 1= Transient cough before sleep or occasional cough during the night; 2 = Cough mildly affecting night sleep; 3 = Cough severely affecting night sleep.'}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Day 0, Day 1, Day 2, Day 3', 'description': 'Visual Analogue Scale (VAS) for sore throat (0 - 100), with 0 indicates asymptomatic and 100 refers to the most serious or severe symptom.\n\nVAS will be assessed and recorded daily in Subject Diary at time 0, every night time and before the morning dose.\n\nAt the End of Study (last visit) will be assessed by the subject and recorded by the Investigator.'}, {'measure': 'Adverse events', 'timeFrame': 'Day 0, Day 1, Day 2, Day 3', 'description': 'Any adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cough with sore throat', 'Cough without sore throat', 'Reconyl'], 'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized, double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough with/without sore throat.', 'detailedDescription': "Reconyl is a mixed extract from 4 Indonesian herbs, Vitex trifolia (Legundi), Zingiber officinale var. Amarum (Jahe Gajah), Abrus precatorius (Saga), and Phaleria macrocarpa (Mahkota Dewa), which have been known traditionally to relieve cough, respiratory congestion, and sore throat.\n\nThere will be two parallel groups of 30 subjects per group (a total of 60 subjects) planned to be enrolled in this study.\n\nThe investigational product: tablets @ 225 mg of Reconyl. Dose administration: One tablet of Reconyl or Placebo, given 3 times daily, for 3 days.\n\nEligible subjects will be instructed to perform a daily self-assessment on the cough symptoms over the 3 days of treatment, in the Subject Diary. Subject shall return to the study clinic 3 days ± 24 hours after the first dose, for completion of the subject's participation in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy men or women aged 18 to 60 years with cough with/without sore throat with a maximum onset of 3 days.\n2. Signing the informed consent.\n\nExclusion Criteria:\n\n1. Body temperature of \\> 37.3˚C and/or refuse to follow health protocol for COVID-19\n2. Known hypersensitivity to herbal drugs\n3. Pregnant or lactating women\n4. Have received any anti-inflammatory or cough-alleviating drugs within the past 24 hours\n5. Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study\n6. Severe illness, e.g. severe hypertension, any other chronic infections or diseases that may induce cough, such as: pulmonary tuberculosis, gastrointestinal reflux diseases (GERD)'}, 'identificationModule': {'nctId': 'NCT06510257', 'briefTitle': 'Safety and Efficacy Reconyl for Cough With/Without Sore Throat', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dexa Medica Group'}, 'officialTitle': 'Safety and Efficacy of Reconyl for Cough With/Without Sore Throat: A Preliminary Study', 'orgStudyIdInfo': {'id': 'CRSU.P.Dexa/06/20/10.03A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': '1 tablet of Reconyl, 3 times daily', 'interventionNames': ['Drug: Reconyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': '1 tablet of placebo Reconyl, 3 times daily', 'interventionNames': ['Drug: Placebo tablet of Reconyl']}], 'interventions': [{'name': 'Reconyl', 'type': 'DRUG', 'otherNames': ['HerbaKOF'], 'description': '1 tablet of Reconyl, 3 times daily', 'armGroupLabels': ['Treatment Group']}, {'name': 'Placebo tablet of Reconyl', 'type': 'DRUG', 'description': '1 tablet of placebo Reconyl, 3 times daily', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Imeri Fkui', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}, {'city': 'Depok', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Klinik Satelit Makara UI Depok', 'geoPoint': {'lat': -6.4, 'lon': 106.81861}}], 'overallOfficials': [{'name': 'Dewi S Rosdiana, Dr,MD,MKes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dexa Medica Group', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}