Department of Ophthalmology, Otolaryngology, Dermatology, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.
Department of Korean Internal Medicine, College of Korean Medicine, Sangji University, 80 Sangjidae-gil, Wonju-si, Gangwon-do, Republic of Korea.
Trials. 2020 May 18;21(1):410. doi: 10.1186/s13063-020-04265-7.
Cold hypersensitivity in the hands and feet (CHHF) commonly affects Asian women, especially Korean women, and it negatively impacts the quality of life of the affected individuals. One commonly used herbal prescription for treating CHHF is Onkyeong-tang (OKT). Although OKT is widely used clinically in treating CHHF, no randomized clinical trial has been performed to evaluate the efficacy and safety of OKT in the treatment of cold hypersensitivity in the feet (CHF). This clinical trial aims to provide objective evidence for the basis of using OKT in the treatment of CHF in Korean women.
This trial will be a double-blind, randomized, placebo-controlled, parallel-group, multicenter pilot study. A total of 112 participants will be randomly divided into an OKT treatment group or a placebo group with a 1:1 ratio via a web-based randomization system. The OKT and placebo groups will receive prescribed medications orally three times per day (3 g each time) before or between meals for 8 weeks. The primary outcome studied will be the changes in Visual Analog Scale (VAS) scores of CHF from baseline. Secondary outcomes studied will be the VAS score changes of cold hypersensitivity in the hands, changes in the skin temperature of the hands and feet, total scores of the Korean version of the World Health Organization Quality of Life Scale-abbreviated version, and the results of the cold stress test.
This trial will be the first clinical trial to assess the efficacy and safety of OKT in the treatment of CHF. We anticipate that the findings of the study will provide evidence for the basis of using OKT in treating CHF symptoms and generate basic data for designing a further large-scale randomized clinical trial.
Clinical Research Information Service (CRIS): KCT0003723. Retrospectively registered on 8 April 2019.
手脚冷过敏（CHHF）常见于亚洲女性，尤其是韩国女性，会降低患者的生活质量。一种常用于治疗 CHHF 的草药处方是温经汤（OKT）。虽然 OKT 在临床上广泛用于治疗 CHHF，但尚未进行随机临床试验来评估 OKT 治疗足部冷过敏（CHF）的疗效和安全性。本临床试验旨在为 OKT 治疗韩国女性 CHF 提供客观依据。
这是一项双盲、随机、安慰剂对照、平行组、多中心的试验。将 112 名参与者通过在线随机系统以 1:1 的比例随机分为 OKT 治疗组或安慰剂组。OKT 和安慰剂组将在饭前或饭后每天口服 3 次（每次 3g），连续 8 周。主要研究终点为 CHF 的视觉模拟量表（VAS）评分从基线的变化。次要研究终点为手部冷过敏 VAS 评分变化、手部和足部皮肤温度变化、韩国世界卫生组织生活质量量表简表总分、冷应激试验结果。
这将是第一项评估 OKT 治疗 CHF 的疗效和安全性的临床试验。我们预计该研究的结果将为 OKT 治疗 CHF 症状提供依据，并为设计进一步的大规模随机临床试验提供基础数据。
临床研究信息服务（CRIS）：KCT0003723。于 2019 年 4 月 8 日回顾性注册。
