Effectiveness and safety of an ayurvedic nutraceutical for improving clinical parameters of liver function in participants with metabolic dysfunction-associated steatotic liver disease: a randomized, placebo-controlled, preliminary phase 2 exploratory clinical trial.

Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD) lacks treatment options, with few evidence-based choices beyond lifestyle modification. This is the first clinical study to assess the efficacy of an organic liquid oral nutraceutical composed of turmeric extract, dandelion powder, milk thistle extract, and ginger powder in MASLD. Methods: This was a randomized, double-blind, placebo-controlled, preliminary phase 2 exploratory trial conducted at a single center (Sanjivani Super Speciality Hospitals Pvt. Ltd., Gujarat, India) between September 7, 2021 and November 25, 2021. Individuals aged 18-70 years and diagnosed with fatty liver (grades 1-3) were eligible to participate. Participants were randomized 1:1 to receive the test product or placebo, which were both provided as a 60 mL oral solution to be consumed twice daily with a meal for 60 days. The primary endpoint was proportion of participants with improvement in ultrasonography-based fatty liver grading from baseline to Day 60. Results: Fifteen patients each were enrolled in the test product and placebo groups. The mean [standard deviation (SD)] age was 40.6 (10.8) years and 83.3% were male. A significantly higher proportion of patients in the nutraceutical product group had fatty liver grade improvement at Day 60 vs. placebo [60.0% (9/15) vs. 13.3% (2/15); Discussion: This study provides preliminary evidence that this organic nutraceutical may improve steatosis grade in individuals with MASLD. Clinical trial registration: Clinical Trial Registry of India (CTRI/2021/08/035359).