Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study
Author:
Lee Kyou-Young,Han In-Sik,Go Ho-Yeon,Lee Dong-Nyung,Yu Jun-Sang,Sun Seung-Ho
Abstract
Abstract
Background
Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women.
Methods
This trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
Discussion
This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial.
Trial registration
Clinical Research Information Service (CRIS): KCT0003723. Retrospectively registered on 8 April 2019.
Funder
Health Promotion Administration, Ministry of Health and Welfare
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference27 articles.
1. Bae KH, Lee JA, Park KH, Yoo JH, Lee Y, Lee S. Cold hypersensitivity in the hands and feet may be associated with functional dyspepsia: results of a multicenter survey study. Evid Based Complement Alternat Med. 2016;2016:8948690.
2. Kondo M, Okamura Y. Cold constitution: analysis of the questionnaire. Nihon Sanka Fujinka Gakkai Zasshi. 1987;39:2000–4.
3. Cho SG, Go HY, Park JS, Jung KY, Sun SH, Choi YK, et al. Herbal prescription, DSGOST, prevents cold-induced RhoA activation and endothelin-1 production in endothelial cells. Evid Based Complement Alternat Med. 2014;2014:549307.
4. Go HY, Lee JA, Park S, Park S, Park JS, Cheon C, et al. Comparative effects of artemisia vulgaris and charcoal moxa stimulating Zhongwan (CV 12) on body temperature in healthy participants: a cross-over single-blind randomized study. J Tradit Chin Med. 2015;35:551–7.
5. Shin KR, Kwak SA, Lee JB, Yi HR. The effectiveness of hand acupuncture and moxibustion in decreasing pain and “coldness” in Korea women who have had hysterectomy: a pilot study. Appl Nurs Res. 2006;19:22–30..