Comparative Efficacy of Amritadi Kwath and Gokshurak Rasayana in the Management of Chronic Kidney Disease w.s.r Mutravahasrotas Dushti: Protocol of an Open-Label Randomized Controlled Clinical Study

Abstract

Chronic Kidney Disease (CKD) is a major public health concern, particularly in the Indian subcontinent, due to the rising prevalence of diabetes and hypertension. It is characterized by a persistent decline in renal function (eGFR <60ml/min/1.73 m²) or structural kidney damage for more than three months. Gokshura (Tribulus terrestris L), a key herb in Ayurvedic medicine, has shown favourable outcomes in earlier research related to kidney function support. This study focuses on evaluating the efficacy of Amritadi Kwath and Gokshurak Rasayana in improving eGFR and overall renal function in CKD patients. Materials and Methods: This open-label, randomized controlled clinical trial will include 60 participants aged between 25–65 years diagnosed with CKD stages 1 to 3b as per KDIGO 2021 criteria and exhibiting classical symptoms of Mutravaha Srotasdusti. Participants will be randomly allocated using computer-generated randomization into two groups (n=30 each). The trial group will receive Amritadi Kwath and the control group will receive Gokshurak Rasayana for 30 days, followed by a 30-day observational period. The primary outcome measure will be change in eGFR. Secondary outcome measures will include changes in Sr. creatinine, blood urea, Sr. electrolytes, and clinical symptoms such as Atishritam Mutram (polyuria), and Alpa-Alpa Mutra (oliguria), Bahalam Mutram (increase in volume of urine), Shotha (edema), Pandu (anemia). Conclusion: This protocol provides a clinical framework to evaluate Ayurvedic interventions in early-stage CKD and to assess their potential in slowing disease progression and improving patient quality of life.