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临床试验/CTRI/2018/04/013063
CTRI/2018/04/013063已完成3 期

Study of Efficacy,Safety and Tolerability of Ayurvedic Formulation in participants with Diabetic Kidney Disease

Dr Aparna Sathe0 个研究点目标入组 99 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
99

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. Adult ( >18 yrs) either gender with prior diagnosis of DKD.
  • 2. Known case of Type 2 DM diagnosed at least since 6 months.
  • 3. CKD stage 3
  • 3 a : e GFR (EPI) 45 to < 60
  • 3 b : e GFR (EPI) 30 to < 45
  • 4. Participants on stable and acceptable dose of ACE inhibitors or ARB (angiotensin II receptor blockers)

排除标准

  • 1)Type I DM
  • 2)Lack of clinical evidence or suspicion of renal diagnosis other than DKD
  • 3)UACR > 5000mg/g on any major measurement during screening.
  • 4)Uncontrolled Diabetes (HB1Ac > 8%)
  • 5)ESRD receiving dialysis or Anticipated progression to ESRD within treatmentperiod.
  • 6)Status postrenal transplant.
  • 7)Unstable CVD
  • 8)Other concomitant disease that could impair patients safety or ability to participate in study.
  • 9)Known case of Immunocompromised patients or subjects on immunorupressive drugs.
  • 10)Pregnant and lactating females.

研究者

发起方
Dr Aparna Sathe

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