A Clinical trial to study the effects of a unani formulation 'Diabeat'in patients with high blood sugar levels (Type 2 diabetes mellitus )
- Registration Number
- CTRI/2009/091/000702
- Lead Sponsor
- Hamdard National Foundation New DElhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Patients of type-2 diabetes mellitus, age 30-60 years taking Metformin for more than 3 months with uncontrolled hyperglycaemia i.e.HbA1C between 7% to 9% and Body Mass Index (BMI) between 25-29.9 kg/m2.
2. Patients who are able and willing to follow anti-diabetic therapy under a stable life style and diabetic diet.
3.Patients who are willing and able to understand and follow the protocol and provide informed consent.
1.History of treatment with any insulin
2.Diabetes mellitus with complications
3.Pregnant or Lactating women
4.Women of childbearing potential who do not take adequate contraceptive protection.
5.History of hypersensitivity to the Metformin or to drug with similar chemical structure.
6.History of any severe systemic disease.
7.Patients with uncontrolled hypertension.
8.History of drug or alcohol abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean HbA1C 6.5%Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl)Timepoint: 4,8,12 week