Study the Effects of Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Serum IgE level assessments and MAST test
研究概览
简要总结
40 allergic rhinitis patients in the acute phase will be enrolled in the study. All the allergic patients should be confirmed those who are over 20 years old and hypersensitive to house dust mite allergens confirmed by MAST test before study. All patients were treated with mixed formula of Chinese medicine for one months.
详细描述
Perennial allergic rhinitis is an important disease in traditional Chinese medicine (TCM) due to its high prevalence rate in Taiwan. In our previous studies, a new mixed formula of Chinese herbs was evaluated for the treatment of allergic rhinitis. In these studies, we found that immunoduoatory effects of Chinese medicine include: CD4+ T lymphocytes; Regulatory T cells; Dendritic cells, and Regulatory B cells. These results allow us to confirm the immunomodulatory effects of mixed formula of traditional Chinese medicine. In recent years, more and more attention has been paid to the effects of gut microbiota on immune-modulation. Many immunomodulaotry effects of allergic diseases were considered to be closely related to gut bacteria. However, the research on allergic rhinitis is still rare, especially related to TCM treatment. From our previous studies, it has been confirmed that TCM have an immunomodulatory effect on allergic rhinitis. Whether or not they are associated with gut microbiota changes is still unknown. This year, we compared the difference of composition and diversity of gut microbiota of allergic rhinitis patients and normal individual. Indeed, we found it were different between allergic patients and normal individuals. The results of this study will provide us the information to understand whether the immunemodulation of TCM treatment on allergic rhinitis is correlated with the changes of gut microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer for study enrollment and sign inform consent
- •Mite allergy confirmed by MAST test
- •Over 20 years old
- •Will have their blood collected twice and stool samples
- •Allergic rhinitis patients in the acute phase will be treated with mixed formula of Chinese medicine for one months
排除标准
- •Women who are pregnant or breast-feeding
- •Under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month
- •Under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on vasomotor type allergic rhinitis
- •History of allergy or adverse effect to Chinese herbs, poor compliance of herbal medicine severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR <60 mL/min/1.73 m2)
研究组 & 干预措施
mixed Chinese herb formula
Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day
干预措施: Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day (Drug)
结局指标
主要结局
Serum IgE level assessments and MAST test
时间窗: On starting day (day 0)
check serum total IgE and mite specific IgE
次要结局
- CD4+ Cell isolation and purification(Assessment of CD4+ on Day 0 and 1 month after completing treatment)
- Quantification of mRNA expression by means of RT-PCR and real-time PCR(Assessment of mRNA on Day 0 and 1 month after completing treatment)
- Gut microbiota data analysis procedures(Assessment of gut microbiota on Day 0 and 1 month after completing treatment)
研究者
YANG SIEN-HUNG
Director of Department of Traditional Chinese Medicine
Chang Gung Memorial Hospital