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: 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 body mass index ≥ 25 kg/m2 and will have NAFLD. 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: This study will explore the effect of DST on weight loss and obesity-related markers, along with NAFLD-related clinical parameters in obese patients with NAFLD to conduct further large-scale trials. Furthermore, it will provide insight into the DST pharmacological mechanism of action through a gut microbiome analysis Trial registration: Korean Clinical Trial Registry, KCT0003554. Registered on 25 February 2019, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=13379

Effects of Jia Wei Dachaihu-Tang on gut microbiota and inflammatory markers in patients with overweight or obesity: study protocol for a randomized, controlled, double-blinded trial

“…There is no clinical study to evaluate the clinical effect of JWDT on on gut microbiota and in ammatory markers in patients with overweight or obesity. Therefore, This study calculated the sample size according to similar studies that had used herbal supplements for weight loss, opinions of medical statistics, and clinical experts [20,21].According to the previous studies and assuming an alpha = 0.05 and power = 0.80 (80%) and the standard deviation of 2.2 for body weight, we would need to recruit 24 subjects in each study arm. After considering the dropout rate of approximately 20%, the sample size for each group is 30 participants.…”