Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The change of the infrared thermography of cold hypersensitivity on hands
研究概览
简要总结
-
Objectives
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to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women
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to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography
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Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity of hands and feet more effectively than placebo after 8 weeks administration of interventions- Korean red ginseng or the placebo.
详细描述
Design
- This trial is a randomized, double blind, placebo controlled trial with 80 patients.
- The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea.
- Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up during 4 weeks.
- During the administration period, 6 capsules 2 times a day (1h after breakfast and dinner) of Korean red ginseng or its placebo will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 16 to 60 years
- •Women complaining cold hypersensitivity on hands and feet
- •Thermal deviation between the palm and the upper arm is higher than 0.3℃
排除标准
- •Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
- •Alcohol abuse and alcoholic
- •History of cancer within 5 years
- •Severe depression
- •Hypertension and diabetes
- •Pregnancy or breastfeeding
- •Abnormal finding from blood test at screening visit
- •Allergic to Korean red ginseng
- •Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months
研究组 & 干预措施
Korean red ginseng
The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea). Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).
干预措施: Korean red ginseng (Drug)
placebo
Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng. Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).
干预措施: Placebo (Drug)
结局指标
主要结局
The change of the infrared thermography of cold hypersensitivity on hands
时间窗: baseline and 8 weeks
次要结局
- The change of the infrared thermography of cold hypersensitivity on feet(baseline and 8 weeks)
- The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet(baseline and 8 weeks)
- The change of cold stress test(baseline and 8 weeks)
- The change of Distal-Dorsal Difference(baseline and 8 weeks)
- The change of Heart Rate Variability(baseline and 8 weeks)
- The change of 36-Item Short Form Health Survey(baseline, 8 weeks, and 12 weeks)
研究者
JIN-MOO LEE
Professor
Kyung Hee University Hospital at Gangdong