《Sipjeondaebo-tang 治疗韩国手足寒冷过敏患者的疗效和安全性：一项试验性、随机、双盲、安慰剂对照、平行组临床试验方案》
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.
机构信息
Department of Science in Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.
Department of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, 26339, Republic of Korea.
出版信息
Trials. 2019 Apr 15;20(1):217. doi: 10.1186/s13063-019-3286-7.
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.
背景
冷感过敏症（CHHF）在包括韩国在内的亚洲国家很常见。CHHF 的症状会降低生活质量。特别是，月经疼痛、不孕、白带和不规则出血等妇科疾病可能与 CHHF 有关。四逆汤（SDT）通过平衡阴阳、恢复生理功能恶化、提高免疫力，广泛用于治疗包括 CHHF 在内的各种疾病。然而，SDT 治疗 CHHF 的疗效尚未在临床试验中得到评估。因此，我们旨在通过这项试验研究 SDT 治疗韩国女性 CHHF 的全随机临床试验的可行性。
方法
本研究将是一项先导、随机、双盲、双臂、安慰剂对照、平行组、多中心临床试验。将从五所大学医院招募年龄在 19-59 岁之间出现 CHHF 的女性。将总共 60 名受试者以 1:1 的比例随机分为治疗组（SDT）或安慰剂组。受试者将每天服用 3 克 SDT 或安慰剂，每日 3 次，持续 8 周。主要结局指标将是 CHHF 的视觉模拟量表评分。次要结局指标将是温度计测量的手部和脚部体温变化以及世界卫生组织生活质量量表简表的韩国版变化。
讨论
这将是第一项研究 SDT 治疗 CHHF 疗效和安全性的试验。该研究将为韩国草药治疗 CHHF 提供基本的临床信息，并为设计全随机临床试验提供临床基础。
试验注册
ClinicalTrials.gov，NCT03374345。注册于 2018 年 2 月 15 日。
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