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

Abstract

BackgroundIn 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.MethodsThis 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).DiscussionThis 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 registrationThis study is registered at ClinicalTrials.gov, ID: NCT02645916. Registered on 30 December 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2002-8) contains supplementary material, which is available to authorized users.

DSGOST regulates resistance via activation of autophagy in gastric cancer

“…In cancer chemotherapy, it is of utmost importance to prevent the side effects of anticancer agents. Our robust evidence based on a clinical trial of DSGOST performed on Korean female patients provided evidence of its potential for use as a powerful drug for RP therapy 51 . We hypothesized that DSGOST would help resolve RP that may occur due to chemotherapy using anticancer drug such as cisplatin.…”

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

“…There were many studies on the effects of OKT on gynecological diseases and coldness, but there were no RCTs to examine the safety and efficacy of OKT for CHF. This study has another strength: specifically, the team members engaged in this clinical trial are familiar with the SOPs of this study, as they were part of a previous pilot study that investigated the effects of Danggui-SayukGa-Osuyu-Saenggang-tang [20], Ojeok-san [21], or Sipjeondaebo-tang [22] on CHHF.…”

Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study

“…Thus, our research team is also working on a series of pilot clinical trials of herbal medicine to define the general characteristics of conditions and the efficacy of herbal medicine in patients with CHHF. Among the most prescribed medication, a trial of DSGOST has been performed in several TKM hospitals and was completed in 2017; the results will be published in peer-review journals [ 22 ]. In the second trial in the series, the OJS trial protocol is revised based on the troubleshooting ideas from the DSGOST trial to provide convenient and sufficient procedures to trial staff.…”