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

TL;DR

A new Ayurvedic nutraceutical may improve liver health in people with fatty liver disease, based on a small clinical trial.

Contribution

This is the first clinical study to evaluate an organic nutraceutical for improving liver steatosis in MASLD.

Findings

60% of participants in the nutraceutical group showed improvement in fatty liver grade compared to 13.3% in the placebo group.

The nutraceutical group had a significantly greater mean reduction in fatty liver grading than the placebo group.

Adverse events were mild and similar in both groups, suggesting good safety.

Abstract

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.

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.

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); p = 0.008]. Mean (SD) change in fatty liver grading was −0.60 (0.51) and −0.13 (0.35) for test product vs. placebo (p = 0.007). Adverse events were mild with similar incidence in both groups. The results are limited by the small sample size, single-center design, and short study duration.

This study provides preliminary evidence that this organic nutraceutical may improve steatosis grade in individuals with MASLD.

Clinical Trial Registry of India (CTRI/2021/08/035359).

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