Efficacy and Safety of Chungkookjang, a Fermented Soy Paste, on Histamine-induced Wheal Size
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Histamine-induced Wheal Size
研究概览
简要总结
The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction in a double-blind, randomized, placebo-controlled, human trial
详细描述
Sixty volunteers (aged 20-80) who gave a written consent before entering the study, were randomized in two groups of thirty subjects each. The skin prick test with histamine was performed on the ventral forearm, 10 cm from the elbow, before and after supplement administration, as well as three times daily for 12 weeks of chungkookjang(35g/day) or placebo(35g/day)intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histamine skin prick test: above 3mm
排除标准
- •No medication or cosmetic creams were allowed during Substances the previous week and no drugs containing corticosteroids or ACTH within 3 months.
- •Patients on systemic or topical treatment with immunosuppressive agents on the nondominant arm were excluded
结局指标
主要结局
Changes in Histamine-induced Wheal Size
时间窗: 12weeks
Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).
Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo)
时间窗: 12weeks
Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size was measured in study visit 1(0 week) and visit 3(12 week). Percentage change in histamine-induced wheal size calculations were calculated by the formula ((12weeks - 0weeks) \* 100/0weeks). Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size compared with placebo.
次要结局
- Changes in Eosinophil(12weeks)
- Changes in Immunoglobulin E(12weeks)
- Changes in Serum Histamine(12weeks)
- Changes in Interferon-gamma(12weeks)
- Changes in Interleukin-4(12weeks)
- Changes in Eosinophil Cationic Protein(ECP)(12weeks)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital