Article: AN OPEN-LABEL, SINGLE-ARM, SINGLE-CENTERED CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF YAKRIT PLIHANTAK CHURNA IN SUBJECTS WITH FATTY LIVER

Article Category: Original Research articles

DOI: 10.7897/2277-4343.17117

Pages: 97-107

Author: Vikram Chauhan *, BN Satish

Abstract: Background: Fatty liver disease (FLD), including non-alcoholic (NAFLD) and alcoholic fatty liver disease (AFLD), is a growing global health concern with limited pharmacological options. Yakrit Plihantak Churna (YPC), a classical Ayurvedic polyherbal formulation indicated for Yakrit Roga (liver disorders), is traditionally used for hepatoprotection. Objective: To evaluate the safety and efficacy of YPC in improving liver-related quality of life in patients with fatty liver disease. Materials and Methods: This open-label, single-arm, single-centre interventional trial enrolled 50 patients with ultrasonography-confirmed fatty liver (both NAFLD and AFLD). Participants received 5g of YPC twice daily for 90 days. Assessments using CLDQ, Fatigue Severity Scale (FSS), Liver Disease Symptom Index 2.0 (LDSI 2.0), and General Well-Being Schedule (GWBS) were conducted at baseline and at 30-day interval. Statistical analyses included paired t-tests for within-subject comparisons, with significance set at p < 0.05. Results: Forty-seven participants completed the study. YPC led to significant improvements across all CLDQ domains, including abdominal symptoms (+84%), fatigue (+83%), systemic symptoms (+85%), activity/functioning (+83%), worry (+85%), and emotional distress (+85%), all with p-values < 0.001. FSS scores improved by ~84% (6.53 ? 1.51), LDSI scores by ~55%, and GWBS domains by 74–90%. No adverse events were reported. Compliance exceeded 94%. Conclusion: Yakrit Plihantak Churna was safe, well-tolerated, and significantly improved liver-related symptoms, fatigue, psychological well-being, and overall quality of life. These findings suggest YPC may serve as an effective supportive therapy for fatty liver disease.

Keyword: Fatty liver, Yakrit Plihantak Churna, CLDQ, Fatigue Severity Scale, General Well-Being Schedule, hepatoprotection.