Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial

Abstract

Background: The high prevalence of obesity and non-alcoholic fatty acid disease has become an important public health problem. Daesiho-tang (DST) is an herbal medicine widely used to treat obesity, metabolic syndrome and liver diseases. This pilot study will assess the feasibility of using DST in obese patients with a non-alcoholic fatty liver disease (NAFLD) prior to undertaking a full-scale clinical trial. Methods/design: This is a study protocol for a randomised, double-blind, parallel-group, stratified, placebo-controlled pilot trial. We will recruit a total of 60 participants with NAFLD who have a body mass index ≥ 25 kg/m 2 . They will take either DST or placebo (3 g, three times daily) for 12 weeks with a 4-week follow-up period. The effects of DST will be evaluated by the mean change in body weight as the primary measurement and other secondary parameters (body composition, anthropometric measurements, blood tests, hepatic fat quantification through transient elastography and a physical symptoms questionnaire). Faecal samples will be collected before and after the intervention for a gut microbial analysis.Discussion: In anticipation of conducting further large-scale trials, in this study we will explore the effect of DST on weight loss and obesity-related markers, along with NAFLD-related clinical parameters, in obese patients with NAFLD. Furthermore, it will provide insight into the DST pharmacological mechanism of action through a gut microbiome analysis.

Targeted bile acid profiles reveal the liver injury amelioration of Da-Chai-Hu decoction against ANIT- and BDL-induced cholestasis

“…Of note, serum CA and TC levels in mice with intrahepatic and extrahepatic cholestasis significantly decreased after DCHD intervention. Study results show that DCHD has the potential to treat obesity and nonalcoholic fatty liver disease (Han et al, 2020). Upon DCHD treatment, the triglyceride content in hepatocytes was significantly reduced, and the fat deposition in the liver was reduced (Nakayama et al, 2007;.…”

Da-Chai-Hu-Tang Protects From Acute Intrahepatic Cholestasis by Inhibiting Hepatic Inflammation and Bile Accumulation via Activation of PPARα

“…Our network pharmacology-based approach established PPARα as the core element of DCHT’s visual Herb-Compound-Target-Disease network ( Supplementary Figure S4 ). This may explain why DCHT is considered as a treatment of obesity and hyperlipidemia ( Umeda et al, 1989 ; Han et al, 2020 ), since PPARα plays a central role in the onset and progression of these diseases ( Xu et al, 2018 ). Whether DCHT is a direct or indirect PPARα agonist awaits further investigation.…”

“…It exhibits multifaceted pharmacological bioactivities against diseases such as pancreatitis, hypercholesterolemia, diabetes, hyperlipidemia, gastritis, habitual constipation, obesity, etc. ( Umeda et al, 1989 ; Yoshie et al, 2004 ; Duan et al, 2017 ; Han et al, 2020 ; Lian et al, 2020 ). Previous clinical study showed that DCHT improved clinical outcome against cholestatic liver injury ( Song et al, 2019 ).…”

Dachaihu decoction inhibits hypernutrition-induced liver metastasis from colorectal cancer by maintaining the gut vascular barrier

“… 24 , 25 DCHD has also been shown to have significant beneficial effects in type 2 diabetes mellitus 26 and nonalcoholic fatty liver disease. 27 , 28 …”