Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Improvement clinical symptoms of Allergen Rhinitis
研究概览
简要总结
This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result of the self and between-group cross-reference by two questionnaires filled before and after treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet allergic rhinitis (include allergic rhinitis with asthma) diagnostic criteria at Peking Union Medical College Hospital Department of Allergy;
- •have allergic rhinitis in episodes.
- •without antihistamine,local anaesthetic or traditional Chinese medicine in last months.
- •signed the informed consent form.
排除标准
- •have severe deviation of nasal septum and nasal polyps.
- •have nasal surgery or a history of cancer(tumor).
- •have other serious illness or evidence of mental disorders.
- •female in pregnancy and lactation
研究组 & 干预措施
Qufeng Shengshi Fang and Loratadine
Qufeng Shengshi Fang is a traditional Chinese medicine form 8 kinds of herbs. Loratadine is the second generation antihistamines, after converted into its active metabolite Carrie period (carebastine), its antihistamines and allergy effect has been demonstrated in vitro and in vivo tests, also received data from clinical trials.
干预措施: Qufeng Shengshi Fang and Loratadine (Drug)
Qufeng Shengshi Fang and Loratadine
Qufeng Shengshi Fang is a traditional Chinese medicine form 8 kinds of herbs. Loratadine is the second generation antihistamines, after converted into its active metabolite Carrie period (carebastine), its antihistamines and allergy effect has been demonstrated in vitro and in vivo tests, also received data from clinical trials.
干预措施: Loratadine (Drug)
Loratadine
Loratadine (INN) is a second-generation H1 histamine antagonist drug used to treat allergies. In structure, it is closely related to tricyclic antidepressants, such as imipramine, and is distantly related to the atypical antipsychotic quetiapine.Loratadine is marketed by Schering-Plough[needs update] under several trade names (e.g., Claritin) and also by Shionogi in Japan. It is available as a generic drug and is marketed for its nonsedating properties. In a version named Claritin-D or Clarinase, it is combined with pseudoephedrine, a decongestant; this makes it useful for colds, as well as allergies but adds potential side effects of insomnia, anxiety, and nervousness.
干预措施: Qufeng Shengshi Fang and Loratadine (Drug)
Loratadine
Loratadine (INN) is a second-generation H1 histamine antagonist drug used to treat allergies. In structure, it is closely related to tricyclic antidepressants, such as imipramine, and is distantly related to the atypical antipsychotic quetiapine.Loratadine is marketed by Schering-Plough[needs update] under several trade names (e.g., Claritin) and also by Shionogi in Japan. It is available as a generic drug and is marketed for its nonsedating properties. In a version named Claritin-D or Clarinase, it is combined with pseudoephedrine, a decongestant; this makes it useful for colds, as well as allergies but adds potential side effects of insomnia, anxiety, and nervousness.
干预措施: Loratadine (Drug)
结局指标
主要结局
Improvement clinical symptoms of Allergen Rhinitis
时间窗: 0，4 and 8 weeks
Clinical symptoms of Allergen Rhinitis including Rhinocnesmus (0: No symptom；1：Intermittent；2：Formication but supportable；3：Formication and insupportable)，Sneeze (0: No symptom；1：3-5 times everyday；2：6-10 times everyday；3：\>11 times everyday)，Rhinorrhea (0: No symptom；1：modicum；2：medium；3：mass)，Rhinobyon (0: No symptom；1：Conscious inspiratory；2：Intermittent；3：Mostly breathing through mouth)，Itchy eyes(0: No symptom；1：Pruritus but supportable；2：Need rub eyes occasionally；3：Need rub eyes frequently)，Racryorrhea (0: No symptom；1：With sneezing；2：between 1and 3；3：No sneeze also )，Itchy ears and palate(0: No symptom；1：Intermittent；2：Pruritus but supportable；3：Pruritus and insupportable). Assessing the change by comparing the symptom score before and after treatment.
次要结局
- Renal Function Examination(0，4 and 8 weeks)
- Secretory immunoglobulin E Examination(0 and 8 weeks)
- Liver Function Examination(0，4 and 8 weeks)
- Blood Routine Examination(0，4 and 8 weeks)
- Change of Exosomes(8 weeks)
- Urine Routine Examination(0，4 and 8 weeks)
- Fractional Exhaled Nitric Oxide Examination(0 and 8 weeks)
- Pulmonary function Examination(8 weeks)
- Test of Cytokine(8 weeks)
- Test of Metabonomics(8 weeks)
- Test of Proteomics(8 weeks)
- IncRNA Sequencing(8 weeks)