CTRI/2014/09/005048尚未招募2 期
CLINICAL EVALUATION OF GOKSHURADI GUGGULU AND GUDUCHI CHURNA IN THE MANAGEMENT OF TYPE II DIABETES MELLITUS (MADHUMEHA) - CEGGMDM
Central Council for Research in Ayurvedic sciences CCRAS0 个研究点目标入组 58 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
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 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.
排除标准
- •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.
研究者
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