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
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