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

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, 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

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.

Keywords: Cold hypersensitivity; Cold intolerance; Herbal medicine; Sipjeondaebo-tang.

Conflict of interest statement

Ethics approval and consent to participate

This trial has been approved by the IRBs of five hospitals (Gachon University Gil Korean Medical Hospital: 17–105, Kyung Hee University Oriental Medical Center: KOMCIRB-171117-HR-048-03, Kyung Hee University Korean Medicine Hospital at Gangdong: KHNMCOH2017–11-004, Korean Medical Hospital of Sangji University: SJIRB-17-001, and Semyung University Second Affiliated Korean Medical Hospital at Chungju: 1711–18). The study will be performed according to the Helsinki Declaration and the Good Clinical Practice Guidelines of the Korea Food and Drug Administration. Written informed consent will be obtained from all subjects prior to any clinical trial procedures. If any issue which may have impacted to the performance of the trial is occurred, it should be approved by the site IRB prior to implementation. After the site approval, each site staffs must be notified and trained before conducting the trial.

The results of the trial will be disseminated through scientific journals or presentations at scientific conferences. So far, the public access to any trial data set is still unplanned.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant timeline for the Sipjeondaebo-tang (SDT) study

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