Clinical Evaluation of Saptavimshatika Guggulu and Haridra Churna in the Management of Type II Diabetes Mellitus. - ACT- DM-2010

Department of AYUSH Ministry of Health Family Welfare Government of India0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

发起方

Department of AYUSH Ministry of Health Family Welfare Government of India