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
- Conditions
- Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents
- Interventions
- Registration Number
- NCT00940251
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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.
Patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mersina, Diet and exercise Mersina - CORN STARCH Mersina -
- Primary Outcome Measures
Name Time Method antidiabetic activity 3 months
- Secondary Outcome Measures
Name Time Method Improvement in metabolic, insulin level, HbA1c,kidney and lipid profile 3 months
Trial Locations
- Locations (1)
Jyoti Clinical and Pathological Laboratory
🇮🇳Shirpur, Maharashtra, India