Status:

COMPLETED

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

Lead Sponsor:

Jyoti Clinical and Pathological Laboratory

Conditions:

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

Eligibility:

All Genders

30-60 years

Phase:

PHASE2

Brief 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, stud...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2008

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT00940251

Start Date

September 1 2008

End Date

November 1 2008

Last Update

July 15 2009

Active Locations (1)

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Jyoti Clinical and Pathological Laboratory

Shirpur, Maharashtra, India, 425 405