A pilot study exploring the efficacy and safety of herbal medicine on Korean obese women with metabolic syndrome risk factors: Double blinded, randomized, multicenter, placebo controlled study protocol clinical trial
Hyun-Ju Kim, Youme Ko, Hojun Kim, Yun-Yeop Cha, Bo-Hyoung Jang, Yun-Kyung Song, Seong-Gyu Ko, Hyun-Ju Kim, Youme Ko, Hojun Kim, Yun-Yeop Cha, Bo-Hyoung Jang, Yun-Kyung Song, Seong-Gyu Ko
Abstract
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).
Conflict of interest statement
The authors have no conflicts of interest to disclose.
The authors declare that they have no competing interests.
References
- Seo MH, Kim YH, Han K, et al. Prevalence of obesity and incidence of obesity-related comorbidities in Koreans based on National Health Insurance Service Health Checkup Data 2006-2015. J Obes Metab Syndr 2018;27:46–52.
- Park JH, Yoon SJ, Lee H, et al. Burden of disease attributable to obesity and overweight in Korea. Int J Obes (Lond) 2006;30:1661–9.
- Kang JH, Jeong BG, Cho YG, et al. Socioeconomic costs of overweight and obesity in Korean adults. J Korean Med Sci 2011;26:1533–40.
- Yi DY, Kim SC, Lee JH, et al. Clinical Practice Guideline for the Diagnosis and Treatment of Pediatric Obesity: Recommendations from the Committee on Pediatric Obesity of the Korean Society of Pediatric Gastroenterology Hepatology and Nutrition. Pediatr Gastroenterol Hepatol Nutr 2019;22:1–27.
- Liu Y, Sun MY, Yao H, et al. Herbal medicine for the treatment of obesity: an overview of scientific evidence from 2007 to 2017. Evid Based Complement Alternat Med 2017;2017:8943059.doi: 10.1155/2017/8943059. Epub 2017 Sep 25.
- Heo J. Donguibogam. Seoul: Namsandang; 1980. pp. 1, 69, 82, 104, 597, 601. Korean.
- Hussain A, Yadav MK, Kim HJ, et al. Daesiho-Tang is an effective herbal formulation in attenuation of obesity in mice through alteration of gene expression and modulation of intestinal microbiota. PLoS One 2016;11:e0165483.doi: 10.1371/journal.pone.0165483. eCollection 2016.
- Lee J-M. Dongeuisusebowon-Sasang-Chobonkwon, Translate by S. G. Park. Seoul, Korea: Jiwentang; 2003.
- Seo DM, Lee S H, Lee F Clinical observation on effects and adverse effects of choweseuncheng-tang on obesity patients. J Korean Acupunct Moxibustion Soc 2005;22:145–53.
- Park HS, et al. Development of Korean version of obesity-related quality of life scale. Kor J Obes 2003;12:280–93.
- Rhee MK, et al. A standardization study of the Korean version of eating attitude test26 I: reliability and factor analysis. Korean J Psychosomatic Med 1998;6:155–75.
- Choi S, et al. A study on the association between Sasang Constitutions (QSCC II) and Huh's morphological diagramming. Korean J Oriental Med 2002;8:75–92.
- Kang BG, Moon JS, Choi SM. A reliability analysis of syndrome differentiation questionnaire for obesity. Korean J Orient Med 2007;13:109–14.
- Korean Institute of Oriental Medicine (KIOM, the society of Korean medicine for obesity, research). Korean Medicine Clinical Practice Guideline for Obesity. Daejeon, South Korea: Elsevier; 2016.
Source: PubMed