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| Name | Class |
|---|---|
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
| Third Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huang-long Zhi-xiao Granule | Experimental | 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. |
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| Huang-long Zhi-xiao Granule placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huang-long Zhi-xiao Granule | Drug | The experimental group was given Huang-long Zhi-xiao Granule.1 dose per day, oral in 2 divided doses, 1 course every 4 weeks, for a total of 8 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control tests（CAT） | 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. | Change from baseline CAT scores at week 4, 8, 21, 34，47 and 52. |
| Frequencies of acute attacks | 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. | Up to week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma exacerbation severity and hospitalization rate | Worsening lung function during asthma attacks is characterized by decreased expiratory flow, and the severity of the exacerbation can be graded by the patient's symptoms, lung function, and arterial blood gas analysis.According to the frequency of daytime and nighttime asthma attacks and pulmonary function test results, the patients were divided into 4 grades, namely: 1 intermittent attack; 2 mild persistent; 3 moderate persistent and 4 severe persistent.The severity of the asthma attack was assessed using a rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minghang Wang, MD | Contact | 0371-66248624 | wmh107hn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Minghang Wang, MD | Henan University of Traditonal Chinese Medicine | Principal Investigator |
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| Huang-long Zhi-xiao Granule placebo | Drug | The toncral group was given placebo Huang-long Zhi-xiao Granule.The course of treatment was the same as that of the experimental group. |
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| Week0(before treatment),week4、week8、week21、week34、week47and week52. |
| Change in severity of chronic persistent disease | Although the patient does not have an acute attack of asthma, there are still symptoms such as wheezing, cough, chest tightness and other symptoms with different frequency and degrees for a long time, which may be accompanied by decreased pulmonary ventilation function. The severity of chronic persistent asthma can be classified into four levels: intermittent, mildly persistent, moderately persistent, and severely persistent, according to the frequency of daytime and nighttime asthma symptoms and the results of pulmonary function tests.The severity of the asthma attack was assessed using a rating scale | Week0(before treatment),week4、week8、week21、week34、week47and week52. |
| The dose used by glucocorticoids | Corticosteroids are the drug of choice for long-term asthma treatment. The vast majority of patients with chronic persistent asthma are well controlled by inhaling low-dose corticosteroids (equivalent to 400 micrograms of budesonide per day). | Week0(before treatment),week4、week8、week21、week34、week47 and week52. |
| Rapid-acting beta2 agonists use drugs and doses | Beta2 agonists are asthma drugs that stimulate beta2 receptors distributed on airway smooth muscle to produce bronchodilating effects. These drugs are bronchodilators and are the drugs of choice for acute asthma attacks (airway spasm), which can quickly improve symptoms such as dyspnea, cough, etc. If given by inhalation, salbutamol 100-200mcg or terbutaline 250-500mcg at a time and repeat every 20 minutes if necessary, | Week0(before treatment),week8 and after follow-up（week52） |
| Score for clinical signs and symptoms | Formulate with reference to the "Guidelines for Clinical Research of New Chinese Medicines"Clinical scoring is weighted or assigned according to some of the main symptoms, signs, physiological parameters of patients, etc., so as to quantitatively evaluate the severity of the disease.The higher the score, the worse the state. | Week0(before treatment),week8 and after follow-up（week52） |
| Pulmonary function | Pulmonary function tests are an important part of the assessment of asthma and use objective indicators of lung function to monitor asthma.Routine pulmonary ventilation tests should be performed in all patients with clinically suspected asthma, and bronchodilator tests may be performed if ventilatory function suggests an obstructive change in ventilation. If the diastolic test is positive, the diagnosis of asthma can be established combined with clinical history, if the diastolic test is negative and FEV1 & GT. 70% predicted value, the conditional unit can do bronchial provocation test. | Week0(before treatment),week4、week8、week21、week34、week47and week52. |
| Exhaled nitric oxide | Week0(before treatment),week4、week8、week21、week34、week47and week52. |
| Asthma Control Questionnaire (ACQ) | The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state. | Week0(before treatment),week8 and after follow-up（week52） |
| Asthma Quality of Life Score (AQLQ) score | The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best. | Week0(before treatment),week8 and after follow-up（week52） |
| Sputum detection indicators | ①Induced sputum inflammatory phenotype: the inflammatory phenotype was classified into eosinophilic asthma, neutrophil asthma, paucigranulocytic asthma and mixed granulocytic asthma according to the detection of Eos in sputum②Eosinophil granulocyte cationic protein（EPC）③Inflammatory factors: IL-4, IL-5, Il-13, IL-25④Mucin MUC5AC. | Week0(before treatment), week 8，after follow-up（week52） |