AUGMENTATIVE EFFECT OF MUTRAVIRECHANIYE MAHAKASHAYA GHAN VATI AND MUTRAKRICCHAHAR ARK WITH CONVENTIONAL STANDARD OF CARE IN THE MANAGEMENT OF CHRONIC KIDNEY DISEASE: PILOT STUDY PROTOCOL OF AN OPEN-LABEL RANDOMIZED CONTROLLED TRIAL

Background: Chronic kidney disease (CKD) has emerged as a pressing global health issue, with its prevalence steadily increasing in the Indian population, largely driven by the growing incidence of diabetes. CKD is characterized by a sustained reduction in kidney function (eGFR <60 mL/min/1.73 m²), structural damage, and/or albuminuria (>30 mg/24 h) persisting for more than three months. This study aims to assess the effectiveness of Ayurvedic interventions as adjunctive therapy to standard care in improving eGFR among CKD patients. Materials and Methods: This open-label, randomized controlled trial will enroll 60 participants (30 in each group), aged between 18 and 60 years, diagnosed with CKD as per KDIGO guidelines and presenting with symptoms indicative of Mutravaha Srotodushti. Participants will be randomly assigned to either the intervention group—receiving Mutravirechaniye Mahakashaya Ghan Vati and Mutrakricchahar Ark in addition to conventional allopathic treatment—or the control group, which will receive only the standard allopathic care. The intervention lasts for 30 days, after which a 15-day monitoring phase is carried out. The primary outcome measure is the change in eGFR (calculated via the NKF-KDIGO formula), along with serum creatinine, blood urea, and electrolyte levels (sodium, potassium, calcium, phosphate, bicarbonate). Secondary outcomes assess the alleviation of symptoms associated with Mutravaha Srotodushti (such as polyuria, anuria, oliguria, proteinuria, anemia, dyspnea, and edema) along with enhancement in quality of life, evaluated using the KDQOL-36 questionnaire. Conclusion: This study protocol suggests an integrated clinical approach to assess the role of Ayurvedic formulations in managing Mutravaha Srotodushti, related to CKD. The expected findings aim to help both patients and healthcare providers by offering evidence for an Ayurvedic supplement to standard CKD treatment.