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© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent form of chronic liver disease, with a global prevalence of 25% worldwide, but a consensus treatment is still lacking. Previous studies have shown that Jian-Pi Huo-Xue granules (JPHX) can reduce hepatic steatosis in ultrasound images, but lacked quantitative observation in imagined liver fat content. This study aimed to refine the efficacy and safety assessment of JPHX for NAFLD with magnetic resonance imaging-proton density fat fraction (MRI-PDFF) as the primary outcome.

Methods

This is a randomized, double-blind, placebo-controlled clinical trial. The trial will enrol 84 NAFLD participants who will be equally randomized to receive either JPHX or a placebo for 24 weeks. Follow-up will be performed 12 weeks after the intervention. The primary outcome will be the change from baseline to week 24 in MRI-PDFF. Secondary outcomes will be the body weight, body mass index (BMI), waist circumference, waist-to-hip ratio (WHR), serum liver function, blood lipids and glucose-related indicators, quality of life measurement health survey, and traditional Chinese medicine (TCM) syndrome scale. Outcomes will be monitored at baseline, 12 weeks and 24 weeks after enrolment. Adverse events occurring in this trial will be managed and recorded promptly.

Discussion

We designed a clinical trial for the treatment of NAFLD using JPHX, a TCM formulation that has been shown to have a positive effect on hepatic steatosis in a previous self-controlled trial. This trial will use a more recognized and quantitative imaging approach to demonstrate the efficacy of JPHX in the treatment of NAFLD and observe its safety to provide clinical evidence for its translational applications.

Trial registration

Chinese Clinical Trial Registry ChiCTR2100046132. Registered on 4 May 2021.

Details

Title
Efficacy and safety of Jian-Pi Huo-Xue granule for non-alcoholic fatty liver disease: study protocol for a randomized, double-blind, placebo-controlled trial
Author
Sun, Yuanlong 1 ; Chen, Gaofeng 1 ; Chen, Si 1 ; Wang, Yanjie 1 ; Hu, Yiyang 2 ; Zhao, Yu 1   VIAFID ORCID Logo 

 Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Key Laboratory of Liver and Kidney Diseases (Ministry of Education), Institute of Liver Diseases, Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shanghai, China (GRID:grid.412585.f) (ISNI:0000 0004 0604 8558) 
 Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Key Laboratory of Liver and Kidney Diseases (Ministry of Education), Institute of Liver Diseases, Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shanghai, China (GRID:grid.412585.f) (ISNI:0000 0004 0604 8558); Shanghai University of Traditional Chinese Medicine, Ministry of Education, Institute of Clinical Pharmacology, Shanghai, China (GRID:grid.412540.6) (ISNI:0000 0001 2372 7462) 
Pages
455
Publication year
2022
Publication date
Dec 2022
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2808563512
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.