A clinical study to see the effect of some Ayurvedic formulations in the management of High Blood Sugar.

Phase 2

• Conditions: Health Condition 1: null- Type II Diabetes Mellitus

• Registration Number: CTRI/2012/05/002646
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

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: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex aged between 30 to 65 years

2. Treatment naive patients or diagnosed patients of Type II Diabetes Mellitus taking oral hypoglycemic drugs for <= 6 weeks

3. Patients having Glycosylated haemoglobin (HbA1c) >= 6.5%.

4. Willing and able to participate for 16 weeks

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 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. Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg)

5. Symptomatic patient with clinical evidence of Heart failure.

6. 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.

7. Pregnant / Lactating women.

8. Patient on steroids, oral contraceptive pills or estrogen replacement therapy.

9. Alcoholics and/or drug abusers.

10. Patients with evidence of malignancy

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

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

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

14. Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢ Change in Glycosylated haemoglobin (HbA1c%)Timepoint: At Baseline, on 42nd day and on 84th day.

Secondary Outcome Measures

Name	Time	Method
â?¢ Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) <br/ ><br>â?¢ Change in Blood sugar Fasting. (10-12 hrs after dinner) <br/ ><br>â?¢ Change in Blood sugar Post -Prandial. (100-120 minutes after breakfast) <br/ ><br>â?¢ Change in the SF-36-Health Survey Score.Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. <br/ ><br>SF-36 done at Baseline, at 84th day and at the end of follow up after 16 weeks.