Study of Ayurvedic formulation in Diabetic Kidney Disease.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013063

Enrollment

122

Registered

2018-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 complications Health Condition 3: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: Oral administration of AYurvedic Formulation: Brihatyadi Kashay Ghana in a dose of 4 mg twice daily before food for study duration of 6 months Ingredients 1)Bruhati Solanum Indicum Linn

Eligibility

Inclusion 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 3 b : e GFR (EPI) 30 to 4. Participants on stable and acceptable dose of ACE inhibitors or ARB (angiotensin II receptor blockers)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
!) Participants showing relief from clinical sign and symptoms. 2)Decrease in ACR 3)Increase in EGFREPI Timepoint: Follow up at Every 30days	—

Secondary

Measure	Time frame
Decrease in ACR Increase in EGFREPI Timepoint: At interval of 3 months	—

Countries

India

Contacts

Public ContactDr K R Kohli

R A Podar Ayurved medical college

vdaparnasathe@gmail.com9819216230

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026