NCT00276445终止4 期
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan - A Double-Blind Randomized Study
Meiji University of Oriental Medicine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Symptoms were assessed clinically by score on a allergic symptom rating scale.
研究概览
简要总结
Intravenous- injection of beta-1,3-glucan in human is known to induce T helper type 1 response, while oral uptake did not. It was examined whether superfine dispersed beta-1,3-glucan (SDG) contrived to absorbed by intestinal mucosa would alleviate allergic symptoms by per-oral ingestion
详细描述
Beta-1,3-glucan made from Japanese mushroom is commercially available for healthy foodstuffs. Allergy patients were orally administrated either SDG (n=30) or non-dispersed beta-1,3-glucan (NDG, n=30) and allergic symptoms were assessed clinically, by the double-blind, placebo-controlled, randomized study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •history of seasonal allergic conjunctivitis with or without rhinitis in spring (Japanese cedar pollen season) every year
- •positive allergen specific IgE (> 30 IU/ml) or positive skin prick test result (wheal diameter > 3mm) to Japanese cedar, Orchard Grass pollen, or house dust-mite extract
排除标准
- •Patients who had undergone immunotherapy in the previous 5 years
- •a history of other immunological or medically relevant diseases
结局指标
主要结局
Symptoms were assessed clinically by score on a allergic symptom rating scale.
次要结局
- Total IgE and allergen specific IgE were measured.
- The binding capacity of beta-1,3-glucan to peripheral CD14+ cells were assessed.
研究者
研究点 (2)
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