NCT02006498

A Randomised, Double-blind, Placebo-controlled, Phase II, Single-centre Study to Assess the Safety and Efficacy of Silymarin 700 mg Capsules TID for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Completed Phase 2 Last updated 6 January 2016

What this trial tests

Phase 2 trial testing Sillymarin in Non-alcoholic Fatty Liver Disease in 99 participants. Completed in 1 December 2015.

Timeline

1 June 2012

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	University of Malaya
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	99
Start date	1 June 2012
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	1 location across Malaysia

Drugs / interventions tested

• Sillymarin — full drug profile →
• Placebo

Conditions studied

• Non-alcoholic Fatty Liver Disease — all drugs for Non-alcoholic Fatty Liver Disease →

Sponsor

University of Malaya

Who can join

18 and older, any sex, with Non-alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• To assess the efficacy of Silymarin as defined by an improvement in non-alcoholic steatosis (NAS) activity score by at least 30% from baseline compared to placebo
  Time frame: 12 months

Sponsor's own description

This is a randomised study to examine whether high dose Sillymarin will be able to help improve fat-induced liver damage in the liver. The study hypothesis is that high dose Sillymarin will be able to reduce steato-hepatitis (fat-related liver inflammation) better than placebo.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Randomized Trial of Silymarin for the Treatment of Nonalcoholic Steatohepatitis.
   Wah Kheong C, Nik Mustapha NR, Mahadeva S. · · 2017 · cited 170× · PMID 28419855 · DOI 10.1016/j.cgh.2017.04.016
2. Herbal drug discovery for the treatment of nonalcoholic fatty liver disease.
   Yan T, Yan N, Wang P, Xia Y, et al · · 2020 · cited 162× · PMID 31993304 · DOI 10.1016/j.apsb.2019.11.017
3. Herbal Medicine in the Treatment of Non-Alcoholic Fatty Liver Diseases-Efficacy, Action Mechanism, and Clinical Application.
   Xu Y, Guo W, Zhang C, Chen F, et al · · 2020 · cited 81× · PMID 32477116 · DOI 10.3389/fphar.2020.00601
4. The Molecular Mechanisms of Liver Fibrosis and Its Potential Therapy in Application.
   Zhang D, Zhang Y, Sun B. · · 2022 · cited 64× · PMID 36293428 · DOI 10.3390/ijms232012572
5. Traditional Chinese Medicine in nonalcoholic fatty liver disease: molecular insights and therapeutic perspectives.
   Dai X, Feng J, Chen Y, Huang S, et al · · 2021 · cited 59× · PMID 34344394 · DOI 10.1186/s13020-021-00469-4
6. Efficacy and safety of dietary polyphenol supplementation in the treatment of non-alcoholic fatty liver disease: A systematic review and meta-analysis.
   Yang K, Chen J, Zhang T, Yuan X, et al · · 2022 · cited 57× · PMID 36159792 · DOI 10.3389/fimmu.2022.949746
7. The Impacts of Herbal Medicines and Natural Products on Regulating the Hepatic Lipid Metabolism.
   Li S, Xu Y, Guo W, Chen F, et al · · 2020 · cited 40× · PMID 32265720 · DOI 10.3389/fphar.2020.00351
8. A Molecular Insight into the Role of Antioxidants in Nonalcoholic Fatty Liver Diseases.
   Ezhilarasan D, Lakshmi T. · · 2022 · cited 34× · PMID 35602098 · DOI 10.1155/2022/9233650