Health Condition 1: null- Type II diabetes mellitus (Madhumeha)
Conditions
Interventions
Intervention1: Gokshuradi Guggulu & Guduchi churn: Gokshuradi Guggulu (AFI-I, Page 280, API-II Page 112)
Dose: 1g (Two tablets of 500 mg) twice daily
Dosage form:Tablet of 500 mg
Route of Administra
Sponsors
Central Council for Research in Ayurvedic sciences CCRAS
National Research Institute of Ayurveda Siddha Human resource Development
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycosylated haemoglobin (HbA1c%)Timepoint: At screening and at the end of 12 weeks of treatment. | — |
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: 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. SF-36 and DSQ --At Baseline, on 84th day and on 98th day. | — |
Countries
India
Contacts
Public ContactDr A D JADHAV
National Research Institute of Ayurveda-Siddha Human Resource Development
Outcome results
None listed