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

A Randomized Placebo Controlled Prospective Phase II Clinical Study of an Ayurvedic coded drug AYUSH D on Glycemic Control in Prediabetic Subjects - RAPD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010716

Enrollment

264

Registered

2017-11-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E13- Other specified diabetes mellitus Health Condition 2: null- Prediabetes

Interventions

Intervention1: AYUSH D: Group 2: Diet & Lifestyle modification and Ayurvedic Coded drug AYUSH D , 2 tablets of 1 gram each in 3 divided doses, orally, before meals with lukewarm water for 24 weeks Con

Eligibility

Inclusion 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

Exclusion criteria: 1. Known Cases of DM, both type I and II. 2. Past history of gestational diabetes 3. Subjects on Î²-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.

Design outcomes

Primary

Measure	Time frame
Change in Glycosylated Hemoglobin (HbA1c) from baseline and at 12 weeks and 24 weeks in prediabetics.Timepoint: Change in Glycosylated Hemoglobin (HbA1c) from baseline and at 12 weeks and 24 weeks in prediabetics.	—

Secondary

Measure	Time frame
Change in FBS, PPBS HOMA IR, Plasma Insulin, Lipid profile, BMI and waist circumference, Diabetes Symptoms Questionnaire (DSQ), SF-36 (RAND) Health Survey Score, SAE /ADR laboratory parameters baseline and at 12 and 24 wks.Timepoint: baseline and at 12 and 24 wks.	—

Countries

India

Contacts

Public ContactDr Kishore Kumar R

Regional Ayurveda Research Institute for Metabolic Disorders (CCRAS)

ayurkishore@yahoo.com9845829174

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026