Trial reportBMC complementary medicine and therapies2025
The activity of a herbal medicinal product of Phyllanthus niruri and Silybum marianum powdered extracts (Heptex®) in patients with apparent risk factors for nonalcoholic steatohepatitis: a phase II, multicentered, randomized, double-blind, placebo-controlled clinical trial.
Trial report in BMC complementary medicine and therapies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05343780 (A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of Nonalcoholic Steatohepatitis), which is not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
Who cites it
7 citing papers in PubMed.
- Effect of high dose N-acetyl cysteine supplementation on markers of oxidative stress and insulin resistance in non-diabetic patients with metabolic dysfunction associated steatotic liver disease: a randomized controlled trial.BMC gastroenterology · 2026Trial
- Perioperative gut microbial ecology: a new frontier for improving the prognosis of hepatocellular carcinoma surgery.Precision clinical medicine · 2026Review
- Pachymic Acid Alleviates Non-Alcoholic Fatty Liver Disease via FGF21-Mediated Inhibition of the p38 MAPK Pathway.Food science & nutrition · 2026Article
- Comparative Efficacy of Herbal Products for Improving Liver Enzymes and Inflammation in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Systematic Review and Network Meta-Analysis.Gastro hep advances · 2026Review
- Comparative Efficacy of Herbal Products on Metabolic Parameters in Metabolic-Dysfunction Associated Liver Disease: A Systematic Review and Network Meta-Analysis.Gastro hep advances · 2026Review
- Silymarin-alpha lipoic acid and metabolic dysfunction-associated steatotic liver disease: Insights and methodological considerations.World journal of hepatology · 2025Article
- Therapeutic Potential of Probiotics in Metabolic Dysfunction-Associated Steatohepatitis: A Comprehensive Review.Microorganisms · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNonalcoholic steatohepatitis (NASH) is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by damage and inflammation of hepatocytes. Some medicinal plants have shown antioxidant and anti-inflammatory effects on liver cells. We aimed to investigate the hepatoprotective effect of Heptex® capsules containing 200 mg of Dukung Anak (a powdered extract from aerial parts of Phyllanthus niruri) and 100 mg of Milk Thistle (a powdered extract from fruits of Silybum marianum) in patients with an apparent risk factor for NASH.
methodsThis was a phase II, randomized, double-blind, placebo-controlled, three-arm, interventional clinical trial. Patients were randomized in a 1:1:1 ratio to receive placebo, low dose (one capsule) of Heptex®, or high dose (two capsules) of Heptex®. After 36 weeks, liver enzymes, Fib-4 score, lipid profile, CAP score, and kPa score were evaluated. Patients were monitored for safety throughout the treatment duration.
resultsA total of 146 patients were enrolled in the study. A significant decrease was observed in ALT levels in the low-dose group (57 IU/L to 40 IU/L, p = 0.026) and the high-dose group (61 IU/L to 47.5 IU/L, p < 0.0001) and in AST levels in the high-dose group (43.5 IU/L to 32 IU/L, p = 0.001), with no significant difference between the relative percent change in ALT (p = 0.465) or AST (p = 0.632) between the three groups. No significant difference was revealed between the three groups regarding the median change in Fib-4 score at the end of treatment (p = 0.985). No significant change in the lipid profile was observed in any of the three groups except for the total cholesterol level, which significantly decreased from 210 IU/L to 187 IU/L, p = 0.031 in the low-dose group.
conclusionHeptex® capsules were safe and well tolerated over a treatment period of 36 weeks. However, the hepatoprotective effect in patients at risk of NASH still needs further assessment using more accurate investigation tools, a larger sample size, and/ or higher doses of the combination.
trial registrationRetrospectively registered (registration date: 25/04/2022; trial registration number: NCT05343780).
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