CLINICAL EVALUATION OF CERTAIN AYURVEDIC MEDICINES IN THE MANAGEMENT OF DIABETES MELLITUS

Phase 2

• Conditions: Health Condition 1: null- Type II diabetes mellitus (Madhumeha)

• Registration Number: CTRI/2014/09/005048
• Lead Sponsor: Central Council for Research in Ayurvedic sciences CCRAS

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

1.Diabetics aged between 30 to 60 years.

2.The freshly diagnosed and naive (those who are not taking any Oral Hypoglycaemic Agent.)

3. Patients who are diagnosed to be Type 2 Diabetics by either having Glycosylated haemoglobin (HbA1c) >= 6.5% or BS-F > 126 mg% or BS-PP >200 mg%.

4.Willing to participate.

Exclusion Criteria

1.Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.

2. Patients suffering from Type I Diabetes Mellitus or Brittle Diabetes Mellitus.

3.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

4.Hypertensive patients ( > 140 / 90 mm Hg).

5.Patients with poorly controlled Glycaemic status (HbA1c >8%).

6.Symptomatic patient with clinical evidence of Heart failure.

7.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

8.Pregnant / Lactating women.

9.Patient on steroids, oral contraceptive pills or estrogens replacement therapy.

10.Alcoholics and/or drug abusers.

11.Patients with evidence of malignancy

12.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)

13.H/o hypersensitivity to any of the trial drugs or their ingredients.

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

15.Patients with Microvascular and other complications of Diabetes Mellitus.

16..The patients suffering from Brittle Diabetes.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated haemoglobin (HbA1c%)Timepoint: At screening and at the end of 12 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
â?¢Change in Blood sugar Fasting. (10-12 hrs after dinner) <br/ ><br>â?¢Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) <br/ ><br>â?¢Change in Blood sugar Post - Prandial (100-120 minutes after breakfast) <br/ ><br>â?¢SF-36-Health Survey Score <br/ ><br>Timepoint: Blood Sugar (F) and (PP)--At Screening, on 14th day, on 28th day, on 42nd day, on 56th day, on 70th day, on 84th day and on 98th day. <br/ ><br>SF-36 and DSQ --At Baseline, on 84th day and on 98th day.