Study protocol
Kyoung-Sun Park1,
Jin-Woo Kim1,
Jun-Young Jo1,
Deok-Sang Hwang1,
Chang-Hoon Lee1,
Jun-Bock Jang1,
Kyung-Sub Lee1,
Inkwon Yeo2 and
Jin-Moo Lee1*
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Trials 2013, 14:438 doi:10.1186/1745-6215-14-438
Published: 19 December 2013
Abstract
Background
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.
Discussion
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.
Trial registration
Keywords:
Cold hypersensitivity in the hands and feet; Korean red ginseng; Infrared thermography; Cold stress test; Distal-dorsal difference
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