Article: AN OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF LIVER DETOX FORMULA IN FATTY LIVER DISEASE

Article Category: Original Research articles

DOI: 10.7897/2277-4343.17113

Pages: 63-75

Author: Vikram Chauhan *, BN Satish

Abstract: Background: Fatty liver disease (FLD), encompassing Alcoholic Fatty Liver Disease (AFLD) and Non-Alcoholic Fatty Liver Disease (NAFLD), has emerged as a major global health challenge. Despite its high prevalence and progression risk to cirrhosis or hepatocellular carcinoma, management continues to rely on lifestyle interventions, which are often difficult to sustain. Liver Detox Formula, a proprietary blend of hepatoprotective Ayurvedic herbs such as Katuki, Kalmegh, and Punarnava, has been traditionally used to support liver health. This clinical study aimed to systematically evaluate the safety, efficacy, and tolerability of Liver Detox Formula in patients with AFLD and NAFLD. Objective: To evaluate the impact of Liver Detox Formula on liver-related symptoms, fatigue, digestive disturbances, and overall quality of life over a 90-day period, using validated patient-reported outcomes and clinician assessments. Materials and Methods: An open-label, single-arm, prospective study was conducted in 50 patients (aged 18–65 years) with clinically confirmed AFLD or NAFLD. Participants received 2 capsules (500 mg each) of Liver Detox Formula twice daily after meals for 90 days. Primary efficacy endpoints included change from baseline in Chronic Liver Disease Questionnaire (CLDQ) and Fatigue Severity Scale (FSS) over a 90-day period. Secondary endpoints included symptom-specific checklist scores, clinician-rated disease severity, and symptom improvement. Safety was monitored via adverse event tracking and compliance logs. Statistical significance was assessed using paired t-tests and Wilcoxon signed-rank tests (p < 0.05). Results: Out of 50 enrolled participants, 45 completed the study. CLDQ domain scores showed an average improvement of 82.44% (p < 0.0001). FSS scores decreased from 6.6 to 1.5, reflecting an 85% reduction in fatigue (p = 8.44E-62). Digestive symptoms improved by 77–100%, while clinician assessments reported >90% reduction in disease severity. No adverse events or serious adverse events were observed. Compliance was high (>90%). Conclusion: Liver Detox Formula was found to be safe, well-tolerated, and effective in significantly improving liver-related symptoms, fatigue, emotional well-being, and daily functioning in patients with fatty liver disease. The findings support its role as a promising complementary therapy. Larger randomized trials are recommended for further validation.

Keyword: Liver Detox Formula, Non Alcoholic Fatty Liver Disease, Alcoholic Fatty Liver Disease, Chronic Liver Disease Questionnaire, Fatigue Severity Scale, hepatoprotective herbs.