Efficacy of add-on Dusparshadi Kashaya and Chandraprabha Vati in the management of grade 2 to 3b chronic kidney disease: a structured study protocol of open labelled randomized standard controlled clinical trial

Abstract

Background: Chronic kidney disease (CKD) is a progressive disorder characterized by persistent renal dysfunction, commonly associated with diabetes mellitus and hypertension. Despite advances in conventional management, CKD remains a major global health burden due to its progressive course and complications. In Ayurveda, its clinical manifestations may be correlated with Vrikkaroga described in Bhaishajyaratnavali.

Methods: This single-center, open-label, randomized, standard-controlled clinical trial will enroll participants with grade 2-3 B CKD diagnosed according to kidney disease quality of life (KDIGO) 2024 guidelines. Eligible participants will be randomly allocated to an intervention or control group. The intervention group will receive standard medical treatment plus Dusparshadi Kashaya (120 mL twice daily before meals) and Chandraprabha Vati (500 mg, two tablets twice daily after meals) for 60 days, while the control group will receive standard medical treatment. The primary outcome will be the change in estimated glomerular filtration rate (eGFR) from baseline to day 60. Secondary outcomes will include changes in serum creatinine, serum urea, hemoglobin, and quality of life assessed using the KDQOL™-36 questionnaire. Additional outcomes will include dialysis requirement and mortality. Data will be analyzed using statistical tests, with p<0.05 considered statistically significant.

Conclusions: This study will assess the efficacy and safety of Dusparshadi Kashaya and Chandraprabha Vati as adjuncts to standard care in grade 2-3b CKD and may provide evidence for their potential to improve renal function, quality of life, and clinical outcomes.

Trial Registration: The trial is registered with the Clinical Trials Registry of India (CTRI) (CTRI/2026/05/110662).