A pilot study exploring the efficacy and safety of herbal medicine on Korean obese women with metabolic syndrome risk factors
| Autor: | Kim, Hyun-ju, Ko, Youme, Kim, Hojun, Cha, Yun-Yeop, Jang, Bo-Hyoung, Song, Yun-Kyung, Ko, Seong-Gyu |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
metabolic syndrome risk factors
Adult obesity daesiho-tang Adolescent Pilot Projects Young Adult Study Protocol Clinical Trial Risk Factors Republic of Korea Humans Multicenter Studies as Topic Aged Randomized Controlled Trials as Topic Metabolic Syndrome Patient Selection Middle Aged Medicine Korean Traditional chowiseungcheng-tang Treatment Outcome herbal medicines randomized controlled trial ComputingMethodologies_DOCUMENTANDTEXTPROCESSING Female Anti-Obesity Agents Research Article Phytotherapy |
| Zdroj: | Medicine |
| ISSN: | 1536-5964 0025-7974 |
| Popis: | Supplemental Digital Content is available in the text Background: Obesity is associated with metabolic syndrome, a condition that increases one's risk for heart disease and other conditions. The prevalence of obesity and associated diseases have steadily increased among Korean adults. The effect of the herbal medicines Daesiho-tang (DSHT) and Chowiseungcheng-tang (CST) on obesity have been reported. The purpose of this study is to evaluate the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome. Methods/design: This study is a randomized, double-blinded, placebo-controlled, multi-center, 3-arm, parallel group clinical trial. A total of 120 participants will be enrolled and randomly assigned to the Daesiho-tang group, the Chowiseungcheng-tang group, or the placebo group in a 1:1:1 ratio using an internet-based randomization system at visit 2. Each group will be administered DSHT, CST, or placebo 3 times per day for 12 weeks. The primary outcome is to evaluate the changes in mean body weight of participants in the DSHT and CST groups and compare with those in the placebo group, and determine their statistical significance, if any, after 12 weeks. The secondary outcomes are the following: changes in body fat percentage and body fat mass, changes in waist circumference, waist-to-hip ratio, and body mass index, changes in serum lipids, fasting blood sugar, blood pressure, and C-reactive proteins (CRP) levels between visit 1 and visit 5 measurements. Changes in visceral fat volume determined through abdominal computed tomography, patient-reported health outcomes surveys—the Korean version of the Obesity-related Quality of Life and the Korean version of Eating Attitudes Test. Discussion: This study will provide research methodologies for evaluating the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome. Trial registration: ClinicalTrials.gov, NCT02651454. Registered on 11 January 2016. Protocol version: The final approved version of the trial protocol is V1.3.(2017.11.10). |
| Databáze: | OpenAIRE |
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