Park Kyoung-Sun, Kim Jin-Woo, Jo Jun-Young, Hwang Deok-Sang, Lee Chang-Hoon, Jang Jun-Bock, Lee Kyung-Sub, Yeo Inkwon, Lee Jin-Moo
Department of Gynecology, College of Korean Medicine, Kyung Hee University, Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea.
Trials. 2013 Dec 19;14:438. doi: 10.1186/1745-6215-14-438.
Cold hypersensitivity in the hands and feet (CHHF) is one of the most common complaints among Asians, especially in women. Korean red ginseng (KRG), which is a steamed form of Panax ginseng, has vasodilating action in the peripheral vessels and increases blood flow under cold stress. However, few studies have evaluated the effect of KRG on cold hypersensitivity.
METHODS/DESIGN: This trial is a randomized, double-blind, placebo-controlled trial in 80 CHHF patients. The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea. The participants will take KRG or a placebo for eight weeks, after which they will be followed-up for four weeks. During the administration period, six capsules of 500 mg KRG or placebo will be provided twice a day. The primary outcome is change of skin temperature in the hands between baseline and after treatment. The secondary outcomes include the visual analogue scale scores of cold hypersensitivity in the hands, change of skin temperature and the VAS scores of cold hypersensitivity in the feet, the recovery rate of the skin temperature by the cold stress test of the hands, the distal-dorsal difference of the hands, power variables of heart rate variability, and the 36-item short form health survey.
This study is the first trial to evaluate the efficacy of KRG on CHHF by using infrared thermography. Our study will provide basic evidence regarding CHHF.
CliniacalTrials.gov NCT01664156.
手足冷过敏（CHHF）是亚洲人尤其是女性中最常见的主诉之一。高丽参（KRG）是人参的蒸制形式，在周围血管中具有血管舒张作用，并能在冷应激下增加血流量。然而，很少有研究评估高丽参对冷过敏的影响。
方法/设计：本试验是一项针对80例CHHF患者的随机、双盲、安慰剂对照试验。该试验将在韩国首尔江东庆熙大学医院进行。参与者将服用高丽参或安慰剂八周，之后进行四周的随访。在给药期间，每天两次提供6粒500毫克的高丽参胶囊或安慰剂。主要结局是治疗前后手部皮肤温度的变化。次要结局包括手部冷过敏的视觉模拟量表评分、足部皮肤温度变化和冷过敏的视觉模拟量表评分、手部冷应激试验中皮肤温度的恢复率、手部远端-背侧差异、心率变异性的功率变量以及36项简短健康调查。
本研究是第一项使用红外热成像评估高丽参对CHHF疗效的试验。我们的研究将为CHHF提供基础证据。
ClinicalTrials.gov NCT01664156。
