Health Condition 1: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Saptavimshatika Guggulu Along with Haridra Churna: SAPTAVIMSHATIKA GUGGULU-Dose â?? 1gm (2 Tablets) twice daily
Duration of therapy-12 weeks And HARIDRA CHURNA-Dose â?? 3 gm twice daily
Packing form-Plastic jar containing 30 sachets
Sponsors
Department of AYUSH Ministry of Health Family Welfare Government of India
Eligibility
Inclusion criteria
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 3. Patients having Glycosylated haemoglobin (HbA1c) >= 6.5%. 4. Willing and able to participate for 16 weeks
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in Glycosylated haemoglobin (HbA1c%)Timepoint: At Baseline, on 42nd day and on 84th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) â?¢ Change in Blood sugar Fasting. (10-12 hrs after dinner) â?¢ Change in Blood sugar Post -Prandial. (100-120 minutes after breakfast) 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. SF-36 done at Baseline, at 84th day and at the end of follow up after 16 weeks. | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed