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.
Highlights
In recent years, cold hypersensitivity in the hands (CHH) has become a common ailment of women in Korea
We found that DSGOST relaxes both the endothelial and vascular smooth muscle cells by inhibiting cold-induced activation of the Ras homolog gene family member A (RhoA) and blocks the endothelin-1-mediated paracrine pathway for the cold response in blood vessels [13]
When voluntary withdrawals or urgent medical situations, such as severe adverse events (SAEs), are encountered, the principal researcher of the hospital will inform the sponsor and the contract research organization (CRO) immediately to handle unblinding according to standard operating procedures (SOPs)
Summary
We will recruit 66 participants in total. Once the participant decides to take part in this trial, there will be at least a 2-week run-in period prior to randomization. Each participant will be treated for 6 weeks and visit the clinic once every 2 weeks. The total trial duration will be 8 weeks. Randomization Eligible participants who consent to participate will be randomly assigned to either the treatment (DSGOST) or the placebo group with an allocation ratio of 1:1. Assignment will be done with the web-based randomization system developed by the contract research organization (CRO), the Institute of Safety and Effectiveness Evaluation for Korean Medicine (ISEE). The ability to comply with all study-related procedures, medications, and evaluations
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