Evaluation of the Efficacy and Mechanism of Action of Huang-long Zhi-xiao Granule to Improve the Control Rate of Chronic Persistent of Asthma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 主要终点
- Asthma control tests（CAT）
研究概览
简要总结
The goal of this observational study is to test the Evaluation of the efficacy and mechanism of action about Huang-long Zhi-xiao Granule to improve the control rate of Asthma chronic duration. The main questions it aims to answer are:
- [Relying on the top-level experimental design, scientifically evaluated the efficacy and safety of Huang-long Zhi-xiao Granule in patients with chronic asthma (hot asthma), and provided evidence support for the clinical application of Classical Prescriptions.]
- [Through the retained sample to test Asthma-related inflammatory indicators, immunoglobulins, T cell subsets, etc. To investigate the mechanism of action of Huang-long Zhi-xiao Granule in patients with chronic duration of asthma (hot asthma).]
详细描述
Bronchial asthma attacks are erratic and difficult to heal, which seriously affects the quality of life of patients, and their physical and mental health is also seriously affected by asthma.
This study will conduct clinical observations in patients with chronic persistence (hot wheezing) of bronchial asthma, scientifically evaluate the efficacy and safety of Huanglong Anti-Wheezing in patients with asthma chronic duration (hot wheezing), and provide evidence support for the clinical application of Huanglong Anti-Wheezing Formula.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnostic criteria for chronic persistent bronchial asthma
- •It meets the TCM differentiation standards for wheezing and hot wheezing
- •Asthma Control Test (ACT) questionnaire score<20 score
- •The severity of disease is graded from mild to moderately persistent
- •Patients who have not been treated with anti-asthmatic drugs for 2 weeks prior to dosing or who have been treated with ICS or ICS+LABA for 4 weeks or more prior to dosing and who have the same type and dose of the drug
- •Age form 18-80 years old
- •Have not participated in other clinical studies within 1 month prior to enrollment
- •Voluntarily participate in the study and sign an informed consent form
排除标准
- •Patients with special types of refractory asthma, critical asthma, occupational asthma, seasonal asthma, atypical asthma or tuberculosis, pulmonary interstitial fibrosis, thoracic malformation, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis, allergic granulomatous vasculitis, infectious, restrictive lung disease and other airflow obstructive pulmonary diseases
- •Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 and above, stroke, cerebral hemorrhage, etc.)
- •Glutamate aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 times the upper limit of normal value， blood creatinine (Cr) > upper limit of normal value
- •Those who are allergic and allergic to the components of drugs in known test drugs
- •Patients with bronchiectasis, tuberculosis, pulmonary embolism, or other serious respiratory conditions
- •Combined with severe cognitive and psychiatric abnormalities
- •Participants who are pregnant, lactating, and planning to become pregnant
- •Those who are participating in other clinical trials within 1 month prior to enrollment
研究组 & 干预措施
Huang-long Zhi-xiao Granule
Huang-long Zhi-xiao Granule, Honey ephedra 6g, shot dried 10g, earth dragon 10g, Ganoderma lucidum 20g, Qianhu 12g, perilla seed 10g, Zhejiang fritillary 9g, soaphorn thorn 9g, scorched mulberry white peel 20g, fried white nuts 10g, fructus nume 10g, licorice 6g.
干预措施: Huang-long Zhi-xiao Granule (Drug)
Huang-long Zhi-xiao Granule placebo
The Huang-long Zhi-xiao Granule placebo is prepared by adding 5% of the drug on the basis of dextrin and bitter agent, and its appearance, weight, color and smell are consistent with Chinese medicine granules.
干预措施: Huang-long Zhi-xiao Granule placebo (Drug)
结局指标
主要结局
Asthma control tests（CAT）
时间窗: Change from baseline CAT scores at week 4, 8, 21, 34，47 and 52.
CAT will be used to evaluate quality of life. A total score of 0-40 will be given with a higher score indicating a worse condition.
Frequencies of acute attacks
时间窗: Up to week 52.
It will be assessed by frequencies of asthma-related hospitalizations.The patient's disease progression was recorded by recording the number of acute attacks at each time point, as well as the specific condition at the time of the attack.
次要结局
- The dose used by glucocorticoids(Week0(before treatment),week4、week8、week21、week34、week47 and week52.)
- Pulmonary function(Week0(before treatment),week4、week8、week21、week34、week47and week52.)
- Asthma Quality of Life Score (AQLQ) score(Week0(before treatment),week8 and after follow-up（week52）)
- Change in severity of chronic persistent disease(Week0(before treatment),week4、week8、week21、week34、week47and week52.)
- Asthma exacerbation severity and hospitalization rate(Week0(before treatment),week4、week8、week21、week34、week47and week52.)
- Score for clinical signs and symptoms(Week0(before treatment),week8 and after follow-up（week52）)
- Rapid-acting beta2 agonists use drugs and doses(Week0(before treatment),week8 and after follow-up（week52）)
- Asthma Control Questionnaire (ACQ)(Week0(before treatment),week8 and after follow-up（week52）)
- Sputum detection indicators(Week0(before treatment), week 8，after follow-up（week52）)
- Exhaled nitric oxide(Week0(before treatment),week4、week8、week21、week34、week47and week52.)