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临床试验/CTRI/2017/11/010716
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

发起方
Incharge

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