Study of Ayurvedic formulation in Diabetic Kidney Disease.
- 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
- Registration Number
- CTRI/2018/04/013063
- Lead Sponsor
- Dr Aparna Sathe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method !) Participants showing relief from clinical sign and symptoms. <br/ ><br> <br/ ><br>2)Decrease in ACR <br/ ><br>3)Increase in EGFREPI <br/ ><br>Timepoint: Follow up at Every 30days
- Secondary Outcome Measures
Name Time Method Decrease in ACR <br/ ><br>Increase in EGFREPI <br/ ><br>Timepoint: At interval of 3 months <br/ ><br>