A study of the effect of an Ayurvedic formulation in patients with newly diagnosed Type 2 Diabetes melitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2017/04/008288
- Lead Sponsor
- Clinfound Clinical Research Services PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
1.Patients with FBS >= 130 mg/dl to <= 250 mg/dl.
2.Patients with BMI Ë? 45 kg/m2 .
3.Newly detected Type 2 Diabetes Mellitus (not more than 1 year).
4.The patient with the ability to understand and provide written informed consent form, which must have been obtained prior to screening.
5.Patients willing to comply with protocol requirements
1.Patients with Type 1 Diabetes or secondary form of Diabetes
2.Pregnant, breast feeding, or planning a pregnancy.
3.Patient with history of treatment with Insulin
4.Patient with history of treatment with any antihyperglycaemic agent.
5.Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, GI tract, or central nervous system.
6.Known to have AIDS or HIV positive.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting Blood Sugar and Post Prandial Blood SugarTimepoint: Baseline,Day 30,Day 60,Day 90
- Secondary Outcome Measures
Name Time Method HbA1CTimepoint: Baseline and Day 90;Lipid ProfileTimepoint: Baseline and Day 90;Liver Function TestTimepoint: Baseline and Day 90;Renal Function TestTimepoint: Baseline and Day 90