Shanghai University of Traditional Chinese Medicine
Investigators aimed to assess Jia Wei Yang He Formula as a plus therapy in the treatment of persistent asthma and to explore Airway Microbiome variation of Asthma by Traditional Chinese Medicine treatment
Bronchial Asthma
Jia Wei Yang He granule
Jia Wei Yang He granule Placebo
PHASE2
Asthma is a common chronic inflammatory respiratory disease, patients showed high airway reactivity, and the clinical manifestations of recurrent wheezing, shortness of breath, chest tightness or cough with wheezing dyspnea mainly for a breath. Although many studies have shown that viral infections may be an important cause of asthma seasonal attacks. However, more and more studies have shown that bacterial infection is an important risk factor for asthma. Haemophilus influenzae, Moraxella Mora bacteria infection may increase the risk of asthma by a research report. Chinese medicine decoction, as a common treatment for asthma, can significantly alleviate seasonal attacks and reduce the number of acute attacks. Research shows that Chinese medicine has widely immunomodulatory effects and imbalance of immune system in patients with asthma control, improve the cellular immunity of patients with airway and defense function, significantly reduced asthma attacks of which induced by upper airway infection or chronic persist asthma. This study will be conducted for 4 weeks of standard anti-asthma treatment plus Jia Wei Yang He Formula for patients.Some patients are not willing to use standard treatment such as inhaled corticosteroids and long-acting β-adrenoceptor agonists because of side effects. We will provide these patients free JWYH formula after the efficacy of the JWYH is validated and the subsequent results are considered exploratory. Participants will undergo a physical examination, lung function, blood and sputum collection and all induced sputum samples will be detected by 16S ribosomal RNA (16S rRNA) sequencing and analyzed for microbial bioinformatics. To study whether there is association between the efficacy of Jia Wei Yang He Formula and the changes in microbiota composition.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 240 participants |
| Masking : | TRIPLE |
| Masking Description : | This is a Double-blind Trial |
| Primary Purpose : | TREATMENT |
| Official Title : | Clinical Assessment of Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma and Airway Microbiome Exploration Research |
| Actual Study Start Date : | 2017-10-01 |
| Estimated Primary Completion Date : | 2025-12-01 |
| Estimated Study Completion Date : | 2025-12-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, China, 200032
NOT YET RECRUITING
Fengxian District traditional Chinese medicine hospital
Shanghai, China,
NOT YET RECRUITING
Jingan district center hospital
Shanghai, China,
NOT YET RECRUITING
Pudong Hospital
Shanghai, China,
NOT YET RECRUITING
Shanghai eighth people's hospital
Shanghai, China,
NOT YET RECRUITING
Shanghai TCM-Integrated Hospital
Shanghai, China,
NOT YET RECRUITING
Xuhui district center host
Shanghai, China,
NOT YET RECRUITING
Zhongshan Hospital affiliated fudan university
Shanghai, China,