NCT03299322

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

Clinical Assessment of Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma and Airway Microbiome Exploration Research

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Bronchial Asthma

Interventions

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

Timeline

• Start date: 2017-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2017-10-03
• Last updated: 2024-05-07

Locations

8 sites across 1 country: China