Study on the Mechanism of ZhenQiFuZheng in the Treatment of Allergic Rhinitis Based on Intestinal Flora and Metabolites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analog Score for pain
研究概览
简要总结
ZhenQi FuZheng granules has been used to improve the immune function of human body, protect the bone marrow and adrenal cortex function and promote the recovery of positive function in traditional Chinese medicine care, especially with the immune imbalance diseases like post-surgery, chemotherapy and rhinitis. This project intends to establish AR（allergic rhinitis）specimen library, cell and animal model experiment, combining clinical cohort research with applied basic research, further assess the therapeutic mechanism of ZhenQiFuZheng granules in AR. We assume that ZhenQi FuZheng granules could cause the metabolic omics changes of nasal inflammatory factors and nasal secretions in AR patients, thus improving the type 2 inflammation level of allergic rhinitis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (18-65 years).
- •Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and are diagnosed as allergic rhinitis .
排除标准
- •Patients who refused to accept specimen and questionnaire collection.
- •Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
研究组 & 干预措施
Allergic rhinitis
ZhenQi FuZheng granules (ShiDaiYangGuang)
1 bag at a time, twice a day. Oral for 4 weeks.
干预措施: ZhenQi FuZheng granules (ShiDaiYangGuang) (Drug)
结局指标
主要结局
Visual Analog Score for pain
时间窗: 12 weeks
Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
Rhinoconjunctivitis Quality of Life Questionnaire
时间窗: 12 weeks
Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure
次要结局
未报告次要终点