Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-24 @ 2:03 PM
Study NCT ID:
NCT00940251
Status:
COMPLETED
Last Update Posted:
2009-07-15
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-14', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-14', 'lastUpdatePostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'antidiabetic activity', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ayurvedic formulation', 'type 2 diabetes mellitus', 'secondary failure to oral hypoglycemic agents', 'antidiabetic'], 'conditions': ['Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSecondary failure to Oral Hypoglycemic Agents was diagnosed if the patient had HbA1c levels \\> 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day.\n\nExclusion Criteria:\n\nPatients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency'}, 'identificationModule': {'nctId': 'NCT00940251', 'briefTitle': 'Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Jyoti Clinical and Pathological Laboratory'}, 'officialTitle': 'Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs', 'orgStudyIdInfo': {'id': 'MER1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'CORN STARCH', 'interventionNames': ['Drug: Mersina']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mersina, Diet and exercise', 'interventionNames': ['Drug: Mersina']}], 'interventions': [{'name': 'Mersina', 'type': 'DRUG', 'description': 'capsule, 3g/day, 3 months', 'armGroupLabels': ['CORN STARCH', 'Mersina, Diet and exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '425 405', 'city': 'Shirpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Jyoti Clinical and Pathological Laboratory', 'geoPoint': {'lat': 21.34821, 'lon': 74.88035}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jyoti Clinical and Pathological Laboratory', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jayavant M Jain', 'oldOrganization': 'Jyoti Clinical and Pathological Laboratory'}}}}