Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00396851
Status:
UNKNOWN
Last Update Posted:
2006-11-08
First Post:
2006-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'lastUpdateSubmitDate': '2006-11-06', 'studyFirstSubmitDate': '2006-11-06', 'studyFirstSubmitQcDate': '2006-11-06', 'lastUpdatePostDateStruct': {'date': '2006-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '32501595', 'type': 'DERIVED', 'citation': 'Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly detected type 2 diabetes\n* Fasting plasma glucose \\>126mg/dl\n* HbA1c \\> 7%\n\nExclusion Criteria:\n\n* Serious comorbid illnesss\n* History of drug abuse\n* History of recent weight loss'}, 'identificationModule': {'nctId': 'NCT00396851', 'briefTitle': 'Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'orgStudyIdInfo': {'id': 'Pharma 6/700'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gurmar', 'type': 'DRUG'}, {'name': 'Metformin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'contacts': [{'name': 'Samir Malhotra', 'role': 'CONTACT', 'email': 'samirmalhotra345@yahoo.com'}, {'name': 'Promila Pandhi, MD,DM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'PGIMER', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Samir Malhotra, MD, DM', 'role': 'CONTACT', 'email': 'samirmalhotra345@yahoo.com', 'phone': '+91-172-27552433'}], 'overallOfficials': [{'name': 'Deepak Bhasin, MD,DM', 'role': 'STUDY_CHAIR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, {'name': 'Anil Bhansali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indian Council of Medical Research', 'class': 'OTHER_GOV'}, {'name': 'International Clinical Epidemiology Network (INCLEN) TRUST', 'class': 'NETWORK'}]}}}