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 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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3286-7) contains supplementary material, which is available to authorized users.

Japanese Magazine Articles on Lifestyle Factors Associated with Fertility: A Content Analysis

“…Among the factors mentioned in the magazine articles, there were many descriptions of hypersensitivity to cold, such as coldness and warmth activity (6.69%, 183 of 2737 codes). Hypersensitivity to cold, which has the symptom of feeling cold in the hands and feet more often than others, may be associated or correlated with infertility [49][50][51]. Previous studies suggest that traditional herbal medicine (e.g., Jusen-tai-ho-to) is effective in relieving this symptom [50,51].…”

“…Hypersensitivity to cold, which has the symptom of feeling cold in the hands and feet more often than others, may be associated or correlated with infertility [49][50][51]. Previous studies suggest that traditional herbal medicine (e.g., Jusen-tai-ho-to) is effective in relieving this symptom [50,51]. The hypersensitivity to cold appears to be more frequent in Asian women than in Western populations [50].…”

Study Protocol for Multi-Center, Open-Label, Randomized Controlled Trial for Assessing the Efficacy and Safety of Electroacupuncture for Cold Hypersensitivity in Hands and Feet

“…First, ours is the rst RCT to assess the e cacy and safety of EA for the treatment of CHHF. There have been many RCTs to evaluate the effectiveness and safety of herbal medicines for the treatment of CHHF, but there have been no studies on the treatment of CHHF using EA or acupuncture.Second, the team members in our study had prior experience in RCTs related to CHHF, e.g., a pilot study of Danggui-SayukGa-Osuyu-Saenggang-tang [21], Ojeok-san [22], Sipjeondaebotang [23], Ucha-Shinki-Hwan [24], and Onkyeong-tang [25]; therefore, our study can be conducted more smoothly.…”

“…Several studies have been conducted to evaluate the e cacy and safety of Korean herbal medicines, including Danggui-SayukGa-Osuyu-Saenggang-tang [21], Ojeok-san [22], Sipjeondaebotang [23], Ucha-Shinki-Hwan [24], Onkyeong-tang [25], Korean Red Ginseng [26], for the treatment of CHHF. Studies of acupuncture or EA treatment for coldness have also been conducted.…”

Effect of voluntary breathing exercises on stable coronary artery disease in heart rate variability and rate-pressure product: a study protocol for a single blind, prospective randomized controlled trial

“…The subjects who are withdrawn after randomization will be followed up for outcomes. Reasons for withdrawal will be documented in follow-up records and data will be analyzed using the intention-to-treat (ITT) principle [34].…”