Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged from 18 to 70 years 2.Patient having a diagnosis of chronic kidney disease, with an estimated glomerular filtration rate (eGFR) between 30 to 89 ml/min/1.73 m2 G2-G3b CKD (KDIGO 2012). 3.Serum creatinine level above 1.4 mg/dl and below 5 mg/dl. 4.Serum urea level above 43mg/dl and below 100mg/dl.
Exclusion criteria
Exclusion criteria: 1.Renal artery stenosis. 2.Neoplasm of the kidney. 3.Patients of congenital renal diseases like autosomal dominant and recessive polycystic kidney disease, congenital nephrotic syndrome, Alport s syndrome, Fabry s disease, and juvenile nephronophthisis. 4.Cases with ongoing dialysis therapy or planned for renal transplant. 5.Systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg (confirmed by repeated measurement), within 2 weeks before randomization. 6.A known case of positive Human immunodeficiency virus/Hepatitis B surface antigen/anti- hepatitis C virus antibody. 7.Patient with a history of alcohol or drug abuse. 8.If the patient has a known allergy to the investigation product or any of its ingredients. 9.Pregnant/breastfeeding female at screening or throughout the study period. 10.Vulnerable patients (as defined by ICMR guidelines).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in eGFR (Mean change of score from baseline in 60 days).Timepoint: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in serum creatinine, serum urea level (Mean change of score from baseline in 60 days) 2.Improvement in hemoglobin level (Mean change of score from baseline in 60 days) 3.Improvement of quality of life (with KDQOL -36) (Mean change of score from baseline in 60 days). 3.Hospitalization (number of participants who will need dialysis in 60 days). 4.Mortality (number of events in 60 days).Timepoint: 60 days | — |
Countries
India
Contacts
Institute of Teaching and Research in Ayurveda