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Clinical Trials/CTRI/2017/11/010716
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Incharge

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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