Abstract

BackgroundObesity, which is described as excessive or abnormal body fat, increases the risk of diet-related diseases. In Korea and around the world, the prevalence of obesity has grown annually from 1998 to 2008. This growth has continued despite various therapeutic efforts. The discovery of new and alternative treatments for obesity should be considered an important priority. Taeumjowi-tang (TJ001), a traditional Korean medicinal extract consisting of eight herbs, is a widely used herbal remedy for obesity in Korea. However, the efficacy and safety of TJ001 have not been fully investigated in a clinical trial. The purpose of this pilot study is to estimate obesity-related parameters and to assess the efficacy and safety of TJ001.MethodsOur study is a randomised, double-blind, placebo-controlled, multicentre clinical trial of Taeumjowi-tang (TJ001). For this study, we will recruit obese Korean patients of both sexes, ages 18 to 65 years, from four university hospitals. A total of 104 subjects will be recruited. The participants will receive either 7 g of TJ001 or a placebo three times daily for 12 weeks. The primary end point will be the rate of subjects who lose at least 5% of their baseline body weight. The secondary end points will be changes in body weight, body mass index, waist circumference, hip circumference, waist/hip circumference ratio, lipid profiles, body fat composition, blood pressure, fasting glucose concentration, C-reactive protein and questionnaires related to the quality of life. The outcomes will be measured every 4 weeks. The study period will be 12 weeks and will include a total of five visits with each subject (at screening and at 0, 4, 8 and 12 weeks).ConclusionsThe results of our study will inform various estimates of TJ001 and will serve as the basis for a larger-scale trial. This study will assess the efficacy and safety of TJ001 as an alternative herbal remedy for obesity.Trial registrationCurrent Controlled Trials ISRCTN87153759

Highlights

  • Obesity, which is described as excessive or abnormal body fat, increases the risk of diet-related diseases

  • Hypothesis We hypothesise that the TJ001 responder rates with a 5% or greater weight reduction will be higher than those in the placebo group

  • Our trial could be considered a pilot study, and the efficacy and safety of Taeumjowitang should be assessed in a randomised controlled trial (RCT)

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Summary

Introduction

Obesity, which is described as excessive or abnormal body fat, increases the risk of diet-related diseases. In Korea and around the world, the prevalence of obesity has grown annually from 1998 to 2008. This growth has continued despite various therapeutic efforts. Several nonpharmacological attempts to curb the increase in obesity, including dietary or exercise management, have been largely unsuccessful. These failures have encouraged specialists to develop treatments using pharmacotherapy [2]. Despite these therapeutic attempts, an efficacy and safety limit for conventional weight reduction therapies is apparent [6]. The relative importance and potential benefits of herbal preparations has extended their role as possible alternative methods for obesity therapies

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