CTRI/2017/11/010716进行中(未招募)2 期
A Randomized Placebo Controlled Prospective Phase II Clinical Study of an Ayurvedic coded drug AYUSH D on Glycemic Control in Prediabetic Subjects - RAPD
Incharge0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
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.Subjects of either sex, 18-60 years
- •2.Pre-diabetic subjects with HbA1c of 5.7-6.4%.
- •3.Subjects who agree to participate in the study and submit a written informed consent form
排除标准
- •1.Known Cases of DM, both type I and II.
- •2.Past history of gestational diabetes
- •3.Subjects on β-blockers, thiazide diuretics, corticosteroids, HRT.
- •4.Uncontrolled Hypertensive subjects(with or without medication > 140/90 mmHg)
- •5.Any unstable Heart disease
- •6.Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > greater than ULL),uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects) .
- •7.Pregnant / Lactating women.
- •8.Alcoholics and/or drug abusers
- •9.Patients with evidence of malignancy
- •10.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuroendocrinal disorders, etc.)
- •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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