A trial to study efficacy of FFDP capsules in diabetic patients
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/12/038559
- Lead Sponsor
- Viridis BioPharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Type 2 DM patients (with duration of diabetes > 6 months) and treated with oral hypoglycemic medicines. HbA1c between 7 %to 9% .
2.Patients in the age group between 19 to 65 years, of either sex.
3.Willing to give informed consent.
1.Type 1 DM patients.
2.Type 2 diabetic patients on insulin
3.Pregnant women with diabetes
4.Lactating mothers with diabetes
5.Patient with uncontrolled diabetes, FBG >250mg% or PPBS >400mg% and/or HbA1c > 9.0.
6.Patient with uncontrolled dyslipidemia (fasting S. cholesterol >260mg% and S. triglycerides > 300mg% on screening visit)
7.Patient with presence of any severe diabetic complication and/or major systemic disease.
8.S. Creatinine >1.5%.
9.ASAT and ALT >2.5times the upper normal limits.
10.Patients with recent stroke or unstable angina or coronary artery diseases in previous 6 months before inclusion.
11.Presence of ketone bodies in urine analysis.
12.Haemoglobin level below 10 gm%.
13.History of substance abuse or alcoholism, within the previous one year.
14.Patient with seropositive status.
15.Patients who are on corticosteroids or oral contraceptives.
16.Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
17.Persons who have suffered from HIV/COVID, patients with Hepatitis C as per information given by patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method