To determine safety and efficacy of Food Supplement in patients with type-2 diabetes mellitus in addition to the standard treatment.
Phase 4
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/01/061974
- Lead Sponsor
- Ms Ruchu Kuthiala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Attending clinic / hospital for managing type 2 diabetes mellitus with HbA1c 6.5% or more.
2. There is no change in oral hypoglycemic regimen for at least three months.
3. Patient of any gender between age 35 and 65 years .
4. Patients willing to consent in writing.
Exclusion Criteria
Pregnant and lactating mothers and women intending to become pregnant
Diabetes other than type 2 diabetes mellitus
Patients having complications of diabetes like diabetic neuropathy, retinopathy, nephropathy, ketoacidosis
Participation in any other clinical trial within the last 30 days
Patients with acute infection, any uncontrolled systemic illness or any cancer
Patients with life expectancy less than 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method