Comparative efficacy of Punarnavadi Kwath and Sadabhadradi Churna with conventional standard of care in the management of chronic kidney disease: Protocol of an open-label randomized controlled pilot study

Abstract BACKGROUND: Chronic kidney disease (CKD) is a global health crisis, with rising prevalence in the Indian subcontinent, particularly due to the increasing diabetic population. CKD is defined by a persistent decline in kidney function (eGFR < 60 mL/min/1.73 m²), structural abnormalities, and/or albuminuria (>30 mg/24 h) for at least three months. Previous studies on Ayurvedic interventions, including Punarnava ( Boerhavia diffusa Linn.), have shown promising effects. This study aims to evaluate the efficacy of Punarnavadi Kwath and Sadabhadradi Churna as an adjunct to conventional therapy in improving eGFR in CKD patients. MATERIALS AND METHODS: This open-label randomized controlled trial will include 60 participants (30 per group) aged 18–60 years, irrespective of gender, diagnosed with CKD based on kidney disease: improving global outcomes (KDIGO) criteria and exhibiting symptoms of Mutravaha Srotodushti . Participants will be randomized into two groups: the trial group receiving add-on Punarnavadi Kwath and Sadabhadradi Churna alongside standard allopathic treatment, and the control group receiving only allopathic treatment for 30 days, with a 15-day follow-up. The primary outcome will be the change in eGFR (calculated using a standard NKF-KDIGO equation), along with serum creatinine, blood urea, and electrolyte levels (Na + , K + , Ca² + , PO 4 ³ − , HCO 3 − ). Secondary outcomes will include improvement in Mutravaha Srotodushti symptoms ( Atisritam Mutram —polyuria, Ativibaddham Mutram —anuria, Alpa-Alpa Mutra —oliguria, Bahal Mutram —proteinuria, Pandu —anemia, Shwaskrichhrita —dyspnea, Shotha —edema) and quality of life assessed through KDQOL-36. CONCLUSION: This protocol outlines a clinical investigation using an integrated method to determine the efficacy of Ayurvedic medicines in treating Mutravaha Srotodushti (abnormalities in the urinary system) or CKD. This study’s predicted outcomes will benefit patients and clinicians by providing an integrative Ayurvedic approach to CKD.