study of siddha drug-Aavaaraividai churnam for Diabetes Mellitus
Phase 3
- Conditions
- Health Condition 1: null- Diabetes mellitus
- Registration Number
- CTRI/2015/02/005512
- Lead Sponsor
- Dr K S Uma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.FBS 216-250 mg/dl
2.PBS 200-400 mg/dl
3.HbA1c 7-10 mmol/l
4.Newly diagnosed Diabetes mellitus patients
5. Patients having history of Diabetes mellitus less than 5 years duration
Exclusion Criteria
1Age; < 30 yrs > 60 yrs
2.FBS < 126 > 250 mg/dl
2.PBS < 200 >400 mg/dl
3.HbA1c < 7- > 10 mmol/l
4.Patients having history of Diabetes mellitus more than 5 years duration
5. Patients with Insulin dependent diabetes mellitus
6.Patients with Complications of Diabetes mellitus
7.Patients with gestational Diabetes mellitus
8.Pregnant women /Lactating women /women planning for pregnancy
9. patients not willing to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of HbA1c 1 mmol/dl <br/ ><br>Reduction of FBS 10-50 mg/dl <br/ ><br>Reduction of PPBS 50-100 mg/dlTimepoint: within three months
- Secondary Outcome Measures
Name Time Method Reduction of HbA1c 2 mmol/dl <br/ ><br>Reduction of FBS 10-50 mg/dl <br/ ><br>Reduction of PPBS 50-100 mg/dlTimepoint: within 6 months