Health Condition 1: null- Diabetes mellitus(Madhumeha)
Conditions
Interventions
Intervention1: Nishamalki and Chandraprabha vati: Nishamalki 3 gms daily before food with lukewarm water for 84 days
Chandraprabha vati 1 gms before food with lukewarm water for 84 days
Control Interv
Sponsors
Central Council For Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in Glycosylated haemoglobin (HbA1c%)Timepoint: â?¢ at the end of treatment i.e. 84th day | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in Blood sugar Fasting. (10-12 hrs after dinner) â?¢ Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) â?¢ Change in Blood sugar Post - Prandial (100-120 minutes after breakfast) â?¢ SF-36-Health Survey Score Timepoint: 14th,28th,42nd,56th,70th,84thday and after 2 weeks of follow up syudy | — |
Countries
India
Contacts
Public ContactDr Pradeep dua
Central Council for Research in Ayurvedic Sciences,
Outcome results
None listed