Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 10:53 AM
Study NCT ID:
NCT01905735
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).', 'timeFrame': '6 weeks upto 24 week', 'description': "number of subject with ACR criteria improvement consisting of ACR 20,ACR50,ACR70 reduction in tender and swollen joint counts and 20%,50%,70% improvement respectively in 3 of the following 5 criteria .\n\n1. physician global assessment of disease activity's.\n2. patient global assessment of disease activity's.\n3. subject assessment of pain\n4. subject assessment of function disability via health assessment questionnaire\\[HAQ\\]\n5. acute phase reactant ESR every 6 weeks upto 24 week"}], 'secondaryOutcomes': [{'measure': 'mean change from baseline in tender joint count.', 'timeFrame': '6 weeks upto 24 week'}, {'measure': 'mean change from baseline in swollen joint.', 'timeFrame': '6 weeks upto 24 week'}, {'measure': 'mean change from baseline in physician global assessment of disease activity.', 'timeFrame': 'every 6 weeks upto 24 week', 'description': 'mean change from baseline in physician assessment of disease activity via visual analog scale(0-100 mm)'}, {'measure': 'mean change from baseline in patient global assessment of disease .', 'timeFrame': '6 weeks upto 24 week', 'description': 'mean change from baseline in patient global assessment of disease via visual analog scale(0-100 mm)'}, {'measure': 'mean change from baseline in subject assessment of pain using VAS from 0-100 mm', 'timeFrame': '6 weeks upto 24 week'}, {'measure': 'mean change from baseline in ESR', 'timeFrame': '6 weeks upto 24 week'}, {'measure': 'mean change from baseline in disability index of the health assessment Questionnaire (HAQ)', 'timeFrame': '6 weeks upto 24 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RA'], 'conditions': ['Rheumatoid Arthritis.']}, 'descriptionModule': {'briefSummary': 'the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.', 'detailedDescription': 'it is a multicenter phase 2 ,double blind study in patient with active Rheumatoid arthritis ,there are 2 group in the study A and B ,where group A receive Rhustoxicodendron in 30 potency the first dose will administered orally (1/2 ml)after the completion of case taking ,and repeated every 7th day for 5 month and on the other hand group B receive placebo orally in (1/2 ml) at same interval for same period .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* those who will provide written consent to participate in the study\n* patient willing to turn up for 7th day follow up\n* patient who are willing and compliance to the study\n* those who are between 25 to 60 years .\n* patient who are willing and compliance to the study .\n* ESR more then 28 mm.\n\nExclusion Criteria:\n\n* Participating as a subject in any other clinical research study.\n* Children below the age of 25years.\n* Female subject who are pregnant or planning for pregnancy within 6 month.\n* History of seizures\n* Breast feeding women's.\n* Patient on treatment for life threatening illness like cancer aids etc.\n* Patient should not have any congenital abnormality or patient should not have undergone any operative procedure as consequences of RA."}, 'identificationModule': {'nctId': 'NCT01905735', 'briefTitle': 'A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Healthcare Homoeo Charitable Society'}, 'officialTitle': 'A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .', 'orgStudyIdInfo': {'id': 'SLSGB-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month .', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rhustoxicodendron 30', 'description': '1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.', 'interventionNames': ['Drug: Rhustoxicodendron 30']}], 'interventions': [{'name': 'Rhustoxicodendron 30', 'type': 'DRUG', 'otherNames': ['poison ivy'], 'description': '1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.', 'armGroupLabels': ['Rhustoxicodendron 30']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['dispensing alcohol'], 'description': '1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'mohit gupta, B.H.M.S', 'role': 'CONTACT', 'email': 'dr.mohitgupta@yahoo.in', 'phone': '0091-9212580805'}, {'name': 'mohit gupta, B.H.M.S', 'role': 'SUB_INVESTIGATOR'}, {'name': 'bhuwnesh goyal, B.A.M.S', 'role': 'SUB_INVESTIGATOR'}, {'name': 'prateek singh, B.H.M.S', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Gupta Homoeo Clinic', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '141001', 'city': 'Ludhiana', 'state': 'Punjab', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'seenia sharma, B.H.M.S', 'role': 'CONTACT', 'email': 'drseeniasharma@gmail.com', 'phone': '0091-7837144332'}, {'name': 'mukesh k singh, B.H.M.S', 'role': 'CONTACT', 'email': 'drmukeshkrsingh@gmail.com', 'phone': '0091-9463131239'}, {'name': 'seenia sharma, B.H.M.S', 'role': 'SUB_INVESTIGATOR'}, {'name': 'kuljinder kaur, B.H.M.S', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kochhar Clinic', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}], 'centralContacts': [{'name': 'seenia sharma, B.H.M.S', 'role': 'CONTACT', 'email': 'drseeniasharma@gmail.com', 'phone': '0091-7837144332'}, {'name': 'mukesh k singh, B.H.M.S', 'role': 'CONTACT', 'email': 'drmukeshkrsingh@gmail.com', 'phone': '0091-9463131239'}], 'overallOfficials': [{'name': 'ravinder kochhar, MD hom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Healthcare Homoeo Charitable Society'}, {'name': 'mukesh k singh, B.H.M.S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'health care homoeo charitable society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthcare Homoeo Charitable Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'ravinder kochhar', 'investigatorAffiliation': 'Healthcare Homoeo Charitable Society'}}}}