CTRI/2018/04/013063
Completed
Phase 3
Study of Efficacy,Safety and Tolerability of Ayurvedic Formulation in participants with Diabetic Kidney Disease
Dr Aparna Sathe0 sites99 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- k/c/o/ Diabetic Kidney Disease. 3months k/c/o Type 2 DM at least since 6 months.Health Condition 2: E112- Type 2 diabetes mellitus with kidney complicationsHealth Condition 3: E112- Type 2 diabetes mellitus with kidney complications
- Sponsor
- Dr Aparna Sathe
- Enrollment
- 99
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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