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

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

Study Overview

• Status: Recruiting
• Conditions: Bronchial Asthma
• Intervention / Treatment: Drug: Jia Wei Yang He granule Placebo; Drug: Jia Wei Yang He granule

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zifeng Ma, Master; Phone Number: 1307 +8621-64385700; Email: mzf05@126.com
• Study Contact Backup: Name: Zhenhui Lu, Doctor; Phone Number: 1307 +8621-64385700; Email: tcmdoctorlu@163.com

Study Locations

• China
  • Shanghai, China
    • Not yet recruiting
    • Fengxian District traditional Chinese medicine hospital
    • Contact: Donghua Zhou
  • Shanghai, China
    • Not yet recruiting
    • Jingan district center hospital
    • Contact: Huifang Cao
  • Shanghai, China
    • Not yet recruiting
    • Pudong Hospital
    • Contact: Hong Bao
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Eighth People's Hospital
    • Contact: Dejie Chu
  • Shanghai, China
    • Not yet recruiting
    • Shanghai TCM-Integrated Hospital
    • Contact: Wei Jia
  • Shanghai, China
    • Not yet recruiting
    • Xuhui district center hospita
    • Contact: Ronghuan Yu
  • Shanghai, China
    • Not yet recruiting
    • Zhongshan Hospital affiliated fudan university
    • Contact: Changzhou Shao
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital Affiliated Shanghai University of TCM
      • Contact: Jiyou Fu, master; Phone Number: +8618917763366

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; 80 participants will take oral therapy of 9.25 g Jia Wei Yang He granule Placebo twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.	Drug: Jia Wei Yang He granule Placebo; Made from 1/20 doses which has certain taste, but no therapeutic effect; Other Names: Placebo
Experimental: High dose Treatment Group; Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 18.5g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.	Drug: Jia Wei Yang He granule; This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time; Other Names: Jia Wei Yang He Formula
Experimental: Low dose Treatment Group; Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 9.25g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.	Drug: Jia Wei Yang He granule; This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time; Other Names: Jia Wei Yang He Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test Score variation	Measured the change from Baseline to the end of treatment	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway microbial diversity	Measured by 16S rRNA sequencing of induces sputum	Baseline, 2 weeks and 4weeks
Pulmonary function tests	Measured the change from Baseline to the end of treatment	Baseline and 4 weeks
Fractional exhaled nitric oxide (FeNO)	Measured the change from Baseline to the end of treatment of exhaled nitric oxide	Baseline and 4 weeks
Morning and evening Peak Expiratory Flow (PEF)	Measured the change from Baseline to the end of treatment	Measured during the 4 weeks treatment period
Cytokine levels of serum	Measured the change from Baseline to the end of treatment	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Fudan University
• Investigators: Study Chair: Huiyong Zhang, Master, Longhua Hospital

Publications and helpful links

General Publications

• Jiang W, Ma Z, Zhang H, Lynn HS, Xu B, Zhang X, Bi R, Fu J, Chen Y, Xiao Z, Zhang Z, Lu Z. Efficacy of Jia Wei Yang He formula as an adjunctive therapy for asthma: study protocol for a randomized, double blinded, controlled trial. Trials. 2018 Jul 4;19(1):355. doi: 10.1186/s13063-018-2739-8.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 30, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Bronchial Asthma，TCM，microorganism
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2016LCSY098

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No