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

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

Sponsors

Lead sponsor: Jyoti Clinical and Pathological Laboratory

Source Jyoti Clinical and Pathological Laboratory
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, study of 3 months duration was carried out.

Overall Status Completed
Start Date September 2008
Completion Date November 2008
Primary Completion Date October 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
antidiabetic activity 3 months
Secondary Outcome
Measure Time Frame
Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile 3 months
Enrollment 26
Condition
Intervention

Intervention type: Drug

Intervention name: Mersina

Description: capsule, 3g/day, 3 months

Eligibility

Criteria:

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

Gender: All

Minimum age: 30 Years

Maximum age: 60 Years

Healthy volunteers: No

Location
facility Jyoti Clinical and Pathological Laboratory
Location Countries

India

Verification Date

July 2009

Responsible Party

Name title: Jayavant M Jain

Organization: Jyoti Clinical and Pathological Laboratory

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CORN STARCH

Arm group type: Placebo Comparator

Arm group label: Mersina, Diet and exercise

Arm group type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov