Study

Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis: a Multicentre, Randomised, Placebo-controlled Trial (Phase 2)

Fudan University

PHASE 2 MULTICENTRE RANDOMISED PLACEBO-CONTROLLED TRIAL OF BERBERINE IN NON-ALCOHOLIC STEATOHEPATITIS, TERMINATED 2026

Phase 2 trial planned 89 adults with NASH on berberine vs placebo, Fudan University. Registry status: terminated. Primary completion was November 2024, no results published.

DesignPHASE 2 MULTICENTRE RANDOMISED PLACEBO-CONTROLLED TRIAL OF BERBERINE IN NON-ALCOHOLIC STEATOHEPATITIS, TERMINATED
TierTier 4, Ingredient RCT (different dose)
Year2026
JournalClinicalTrials.gov registry
N89
PublishedAug 16, 2017
Added to NO1GEVITYSep 28, 2026

NCT03198572 randomised 89 adults with non-alcoholic steatohepatitis to berberine or placebo at multiple Chinese centres, sponsored by Fudan University. Phase 2. The registry lists primary completion as 14 November 2024.

The trial is registered as terminated. We found no published results paper as of 28 September 2026. Terminated trials rarely publish: the registry gives no reason for termination, and without results the trial contributes no efficacy data.

Berberine has solid metabolic data outside this trial: multiple randomised trials show lower fasting glucose and HbA1c in type 2 diabetes. The NASH indication remains unproven in humans. This registry entry does not change berberine's evidence grade B.

No results posted. Registry status: terminated; primary completion date 14 November 2024.
Critic notes

Terminated phase 2 trial with no results. Do not count as evidence of effect or harm in either direction.

Editorial decision

registered-trial-terminated-no-results

Terminated registry trial, no published results. Tier 4 registry record only.

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Expected readout: Unlikely to publish given termination. · Decision recorded 2026-09-28

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