A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma

Bronchial Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299322
• Other study ID #: 2016LCSY098
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Zifeng Ma, Master
• Phone: +8621-64385700
• Email: mzf05[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient diagnosed with chronic persistent asthma

• Annual uncontrollable time = 3 months

• Patients who have given written informed consent

Exclusion Criteria:

• History of upper upper/lower respiratory infection in the previous 1 months

• History of long-term controller medication use for asthma (oral corticosteroid or intravenous corticosteroids therapy) within the preceding 1 months

• History of antibiotic use in the previous 1 months

• History of life-threatening asthma

• History of chronic lung diseases other than asthma, including but not limited to chronic obstructive pulmonary disease, bronchiectasis, emphysema, tuberculosis, sarcoidosis, pulmonary fibrosis, lung cancer, etc

• History of serious disease of the heart and cerebrovascular disease

• History of severe liver or renal dysfunction or disease

• History of severe disease in the hematopoietic system

• History of immunodeficiency (including, but not limited to, HIV positive detection, or other acquired or congenital immunodeficiency disease, or organ transplant history)

• History of any other condition (such as known drug or alcohol abuse or psychiatric disorder) which, in the opinion of the investigator, may preclude the patient from following and completing the protocol

• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

• History of allergies to the component of the investigated drugs

• Smoking within the past year

• Contraindication to induced sputum collection method on history or examination

• Any serious medical condition which, in the opinion of the Investigator, would pose a significant risk to the patient or interfere with the interpretation of safety, efficacy, or pharmacodynamic data

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Jia Wei Yang He granule
This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time
• Jia Wei Yang He granule Placebo
Made from 1/20 doses which has certain taste, but no therapeutic effect

Locations

Country	Name	City	State
China	Fengxian District traditional Chinese medicine hospital	Shanghai
China	Jingan district center hospital	Shanghai
China	Longhua Hospital Affiliated Shanghai University of TCM	Shanghai	Shanghai
China	Pudong Hospital	Shanghai
China	Shanghai eighth people's hospital	Shanghai
China	Shanghai TCM-Integrated Hospital	Shanghai
China	Xuhui district center hospita	Shanghai
China	Zhongshan Hospital affiliated fudan university	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test Score variation	Measured the change from Baseline to the end of treatment	Baseline and 4 weeks
Secondary	Airway microbial diversity	Measured by 16S rRNA sequencing of induces sputum	Baseline, 2 weeks and 4weeks
Secondary	Pulmonary function tests	Measured the change from Baseline to the end of treatment	Baseline and 4 weeks
Secondary	Fractional exhaled nitric oxide (FeNO)	Measured the change from Baseline to the end of treatment of exhaled nitric oxide	Baseline and 4 weeks
Secondary	Morning and evening Peak Expiratory Flow (PEF)	Measured the change from Baseline to the end of treatment	Measured during the 4 weeks treatment period
Secondary	Cytokine levels of serum	Measured the change from Baseline to the end of treatment	Baseline and 4 weeks