Ko Youme, Go Ho-Yeon, Han In-Sik, Lee Kyou-Young, Kim Tae-Hoon, Lee Jin-Moo, Jang Jun-Bok, Song Yun-Kyung, Sun Seung-Ho, Jeon Chan-Yong, Ko Seong-Gyu
Department of Korean Preventive Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea.
Department of Korean Internal Medicine, College of Korean Medicine, Semyung University, 65 Semyeong-ro, Jecheon-si, Chungcheongbuk-do, Republic of Korea.
Trials. 2018 Nov 29;19(1):662. doi: 10.1186/s13063-018-3013-9.
This study aims to evaluate the safety, efficacy, and feasibility of a full randomized clinical trial of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet.
This study is a multicenter, double-blinded, randomized, placebo-controlled, two-arm, parallel-group pilot clinical trial. A total of 60 participants will be enrolled and randomly assigned to the Ojeok-san treatment group or the placebo control group, in a 1:1 ratio using an Internet-based randomization system. Each group will be administered Ojeok-san or placebo three times per day for 8 weeks. The primary outcome will be the mean change in the Visual Analog Scale scores of cold hypersensitivity in the hands from baseline to week 8. Secondary outcomes will include the mean changes in the skin temperature of the extremities, recovery rate of the skin temperature of hands after cold stress test, and the score of Korean version of the WHO Quality of Life Scale abbreviated version.
The findings of this study should provide meaningful information for a further large-scale, randomized controlled trial to confirm the safety and efficacy of Ojeok-san on cold hypersensitivity in the hands and feet in female patients.
ClinicalTrials.gov, ID: NCT03083522 . Registered on 20 March 2017.
本研究旨在评估玉泽散对韩国女性手足冷过敏患者进行全面随机临床试验的安全性、有效性和可行性。
本研究是一项多中心、双盲、随机、安慰剂对照、双臂、平行组先导性临床试验。总共将招募60名参与者，并使用基于互联网的随机系统以1:1的比例随机分配到玉泽散治疗组或安慰剂对照组。每组每天服用玉泽散或安慰剂三次，持续8周。主要结局将是从基线到第8周手部冷过敏视觉模拟量表评分的平均变化。次要结局将包括四肢皮肤温度的平均变化、冷应激试验后手部皮肤温度的恢复率以及世界卫生组织生活质量量表简版韩文版的评分。
本研究的结果应为进一步的大规模随机对照试验提供有意义的信息，以证实玉泽散对女性患者手足冷过敏的安全性和有效性。
ClinicalTrials.gov，标识符：NCT03083522。于2017年3月20日注册。
