The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial
Abstract Background Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be re...
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doaj-c47c48f8a43d4ab493ee7be459ce5e332020-11-25T03:00:54ZengBMCTrials1745-62152019-04-012011810.1186/s13063-019-3286-7The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trialYoume Ko0Seung-Ho Sun1In-Sik Han2Ho-Yeon Go3Tae-Hun Kim4Jin-Moo Lee5Jun-Bok Jang6Kyoung Sun Park7Yun-Kyung Song8Kyou-Young Lee9Chan-Yong Jeon10Seong-Gyu Ko11Department of Science in Korean Medicine, Graduate School, Kyung Hee UniversityDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji UniversityDepartment of Korean Internal Medicine, College of Korean Medicine, Sangji UniversityDepartment of Korean Internal Medicine, College of Korean Medicine, Semyung UniversityKorean Medicine Clinical Trial Center, College of Korean Medicine, Kyung Hee UniversityDepartment of Korean Gynecology, College of Korean Medicine, Kyung Hee UniversityDepartment of Korean Gynecology, College of Korean Medicine, Kyung Hee UniversityDepartment of Korean Gynecology, College of Korean Medicine, Kyung Hee UniversityDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon UniversityDepartment of Ophthalmology, Otolaryngology, Dermatology, College of Korean Medicine, Sangji UniversityDepartment of Korean Internal Medicine, College of Korean Medicine, Gachon UniversityDepartment of Science in Korean Medicine, Graduate School, Kyung Hee UniversityAbstract Background Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang (SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19–59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. Trial registration ClinicalTrials.gov, NCT03374345. Registered on 15 February 2018.http://link.springer.com/article/10.1186/s13063-019-3286-7Herbal medicineCold hypersensitivitySipjeondaebo-tangCold intolerance |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Youme Ko Seung-Ho Sun In-Sik Han Ho-Yeon Go Tae-Hun Kim Jin-Moo Lee Jun-Bok Jang Kyoung Sun Park Yun-Kyung Song Kyou-Young Lee Chan-Yong Jeon Seong-Gyu Ko |
spellingShingle |
Youme Ko Seung-Ho Sun In-Sik Han Ho-Yeon Go Tae-Hun Kim Jin-Moo Lee Jun-Bok Jang Kyoung Sun Park Yun-Kyung Song Kyou-Young Lee Chan-Yong Jeon Seong-Gyu Ko The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial Trials Herbal medicine Cold hypersensitivity Sipjeondaebo-tang Cold intolerance |
author_facet |
Youme Ko Seung-Ho Sun In-Sik Han Ho-Yeon Go Tae-Hun Kim Jin-Moo Lee Jun-Bok Jang Kyoung Sun Park Yun-Kyung Song Kyou-Young Lee Chan-Yong Jeon Seong-Gyu Ko |
author_sort |
Youme Ko |
title |
The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial |
title_short |
The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial |
title_full |
The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial |
title_fullStr |
The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial |
title_full_unstemmed |
The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial |
title_sort |
efficacy and safety of sipjeondaebo-tang in korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-04-01 |
description |
Abstract Background Cold hypersensitivity in the hands and feet (CHHF) is frequent in Asian countries including Korea. The quality of life can be degraded by the symptoms of CHHF. In particular, gynecological disorders such as menstrual pain, infertility, leucorrhea, and irregular bleeding may be related to CHHF. Sipjeondaebo-tang (SDT) is widely used in the treatment of various diseases including CHHF by balancing Yin and Yang, restoring the deterioration of physiological function, and improving immunity. However, the efficacy of SDT in the treatment of CHHF has not been assessed in clinical trials. Therefore, we aimed to investigate the feasibility of a full randomized clinical trial of SDT for the treatment of CHHF in Korean women through this trial. Methods This study will be a pilot, randomized, double-blind, two-arm, placebo-controlled, parallel-group, multicenter clinical trial. Women aged 19–59 years who present with CHHF will be recruited from five university hospitals. A total of 60 subjects will be randomly assigned to a treatment group (SDT) or a placebo group at a 1:1 ratio. The subjects will receive 3 g of either SDT or placebo three times daily for 8 weeks. The primary outcome measures will be the Visual Analogue Scale scores of CHHF. The secondary outcome measures will be changes in body temperature in both the hands and the feet as measured using a thermometer and the Korean version of the World Health Organization Quality of Life Scale Abbreviated Version. Discussion This will be the first trial to investigate the efficacy and safety of SDT in the treatment of CHHF. This study will provide basic clinical information regarding Korean herbal medicine treatment of CHHF and a clinical basis for designing a full randomized clinical trial. Trial registration ClinicalTrials.gov, NCT03374345. Registered on 15 February 2018. |
topic |
Herbal medicine Cold hypersensitivity Sipjeondaebo-tang Cold intolerance |
url |
http://link.springer.com/article/10.1186/s13063-019-3286-7 |
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