CTRI/2017/09/009887已完成2 期
Clinical evaluation of Mamajjaka ghanavati in the management of Madhumeha(Type II Diabetes mellitus) - MGV
Central Council of Research in Ayurvedic Sciences0 个研究点目标入组 180 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Diabetics aged between 35 to 65 years.
- •2.Patients who are diagnosed to be Type II Diabetics by having Glycosylated Haemoglobin (HbA1c) between 6.5% - 9% or BS-F between 126 mg% - 200 mg% or BS-PP / Random between 200 mg% - 250 mg%.
- •3. Willing to participate and able to provide signed informed consent.
排除标准
- •1. Patients suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
- •2. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •3.Hypertensive patients ( > 140 / 90 mm Hg).
- •Symptomatic patient with clinical evidence of Heart failure.
- •4.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.
- •5. Pregnant / Lactating women.
- •6. Patient on steroids, oral contraceptive pills or estrogens replacement therapy.
- •7. Alcoholics and/or drug abusers.
- •8.Patients with evidence of malignancy
- •9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •10.H/o hypersensitivity to any of the trial drugs or their ingredients.
- •11.Patients who have completed participation in any other clinical trial during the past six (06) months.
- •12.Any other condition which the Investigator thinks may jeopardize the study.
研究者
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