Study of some Herbal Formulations in the management of Diabetes Mellitus (Madhumeha)

Not Applicable

Completed

• Conditions: Health Condition 1: null- Diabetes mellitus(Madhumeha)

• Registration Number: CTRI/2016/05/006968
• Lead Sponsor: Central Council For Research in Ayurvedic Sciences

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: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Diabetics aged between 30 to 60 years who are on Lifestyle modification &/or on Tab. Metformin upto 2 gm / day.

2.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%.

3.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 1 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 Glycemic 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 estrogen 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.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified