This is a Clinical Trial to Assess if the Coded Ayurvedic Drug AYUSH D brings the Blood Sugar under Control in Prediabetic Subjects

Phase 2

• Conditions: Health Condition 1: E13- Other specified diabetes mellitusHealth Condition 2: null- Prediabetes

• Registration Number: CTRI/2017/11/010716
• Lead Sponsor: Incharge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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.)

11.Patients who have completed participation in any other clinical trial during the past six (06) months.

12.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified