CTRI/2017/11/010716
Active, not recruiting
Phase 2
A Randomized Placebo Controlled Prospective Phase II Clinical Study of an Ayurvedic coded drug AYUSH D on Glycemic Control in Prediabetic Subjects - RAPD
Incharge0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Incharge
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects of either sex, 18\-60 years
- •2\.Pre\-diabetic subjects with HbA1c of 5\.7\-6\.4%.
- •3\.Subjects who agree to participate in the study and submit a written informed consent form
Exclusion Criteria
- •1\.Known Cases of DM, both type I and II.
- •2\.Past history of gestational diabetes
- •3\.Subjects on β\-blockers, thiazide diuretics, corticosteroids, HRT.
- •4\.Uncontrolled Hypertensive subjects(with or without medication \> 140/90 mmHg)
- •5\.Any unstable Heart disease
- •6\.Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT \> 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine \> greater than ULL),uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects) .
- •7\.Pregnant / Lactating women.
- •8\.Alcoholics and/or drug abusers
- •9\.Patients with evidence of malignancy
- •10\.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho\-Neuroendocrinal disorders, etc.)
Outcomes
Primary Outcomes
Not specified
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