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NCT00940251 Clinical Trial

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

Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00940251
Other study ID # MER1
Secondary ID
Status Completed
Phase Phase 2
First received July 14, 2009
Last updated July 14, 2009
Start date September 2008
Est. completion date November 2008

Study information
Verified date July 2009
Source Jyoti Clinical and Pathological Laboratory
Contact n/a
Is FDA regulated No
Health authority India: Indian Council of Medical Research
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date November 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

Secondary 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.

Exclusion Criteria:

Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents
  • Neoplasm Metastasis

Intervention

Drug:
• Mersina
capsule, 3g/day, 3 months

Locations
Country Name City State
India Jyoti Clinical and Pathological Laboratory Shirpur Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Jyoti Clinical and Pathological Laboratory

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary antidiabetic activity 3 months Yes
Secondary Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile 3 months Yes