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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial

Authors: Youme Ko, Ho-Yeon Go, Yoon-Young Cho, Ji-Hye Shin, Tae-Hoon Kim, Dong-Jun Choi, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seong-Gyu Ko, Seung-Ho Sun, Chan-Yong Jeon

Published in: Trials | Issue 1/2017

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Abstract

Background

In recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea. It can lead to gynecological problems such as irregular menstruation, miscarriage, and infertility. Traditionally, Korean herbal medicine has been the primary treatment method used to balance thermoregulation in the human body; however, its effectiveness has not been confirmed through systematic study. Thus, in this trial, we will investigate the feasibility of a full randomized clinical trial, Danggui-Sayuk-Ga-Osuyu-Saenggang-tang (DSGOST) in Korean women with CHH.

Methods

This study will be a pilot, multicenter, double-blind, randomized, parallel-group, two-arm, placebo-controlled clinical trial. A total of 66 participants will be randomly divided into two groups, a DSGOST treatment group and a placebo control group, in a 1:1 ratio using a web-based randomization system. Each group will take DSGOST or placebo three times daily for 6 weeks. The primary outcome will be measured using Visual Analogue Scale (VAS) scores of CHH. Secondary outcomes will include changes in skin temperature of the hands, Clinical Global Impressions (CGI) scale scores, recovery rate of skin temperature of the hands after the cold stress test, and the Korean version of the WHO Quality of Life Scale, abbreviated version (WHOQOL-BREF).

Discussion

This trial will be the first trial to reflect the newly defined disease range of CHH which was compiled by Korean medicine expert consensus. This study will provide considerable evidence for further large-scale trials and general clinical guidelines for CHH in the Korean medical field.

Trial registration

This study is registered at ClinicalTrials.gov, ID: NCT02645916. Registered on 30 December 2015.
Appendix
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Metadata
Title
The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial
Authors
Youme Ko
Ho-Yeon Go
Yoon-Young Cho
Ji-Hye Shin
Tae-Hoon Kim
Dong-Jun Choi
Jin-Moo Lee
Jun-Bok Jang
Yun-Kyung Song
Seong-Gyu Ko
Seung-Ho Sun
Chan-Yong Jeon
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2002-8

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