A clinical study to find the efficacy and safety of Diacare in patients with type 2 diabetes mellitus
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2012/11/003119
- Lead Sponsor
- Admark Herbals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
•Aged 30 to 65 years
•Male and female patients with Type 2 diabetes
•Patients with inadequate glucose control on any anti diabetic drugs
•Body mass index between 20-35 kg/m2
•Having fasting blood glucose > 126 mg/dL
•Post prandial blood glucose > 200 mg/dL
•Having no serious physical or biochemical abnormalities other than those generally associated with type 2 diabetes and who are willing to give written informed consent
•Patients having diabetes other than non insulin dependent diabetes mellitus
•Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs
•Pregnant or lactating women and patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug
•Previous participation in a clinical trial in the last 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Reduction in plasma glucose levels (fasting and post prandial glucose) <br/ ><br>â?¢Reduction in HbA1c level (glycosylated hemoglobin) as compared with baseline <br/ ><br>Timepoint: 3 months <br/ ><br>At day 21, 45 and day 90
- Secondary Outcome Measures
Name Time Method â?¢Incidence of any related adverse effects <br/ ><br>â?¢Vital signs and physical examinations (pulse rate, blood pressure, weight) <br/ ><br>â?¢Selected biochemistry and hematology parameters at baseline and after treatment <br/ ><br>Timepoint: 3 months <br/ ><br>At baseline and day 90