Back to resultsA Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma
Primary Purpose
Bronchial Asthma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jia Wei Yang He granule
Jia Wei Yang He granule Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring Bronchial Asthma，TCM，microorganism
Eligibility Criteria
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
Sites / Locations
- Longhua Hospital Affiliated Shanghai University of TCMRecruiting
- Fengxian District traditional Chinese medicine hospital
- Jingan district center hospital
- Pudong Hospital
- Shanghai eighth people's hospital
- Shanghai TCM-Integrated Hospital
- Xuhui district center hospita
- Zhongshan Hospital affiliated fudan university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control Group
High dose Treatment Group
Low dose Treatment Group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Asthma Control Test Score variation
Measured the change from Baseline to the end of treatment
Secondary Outcome Measures
Airway microbial diversity
Measured by 16S rRNA sequencing of induces sputum
Pulmonary function tests
Measured the change from Baseline to the end of treatment
Fractional exhaled nitric oxide (FeNO)
Measured the change from Baseline to the end of treatment of exhaled nitric oxide
Morning and evening Peak Expiratory Flow (PEF)
Measured the change from Baseline to the end of treatment
Cytokine levels of serum
Measured the change from Baseline to the end of treatment
Full Information
NCT ID
NCT03299322
First Posted
September 21, 2017
Last Updated
May 24, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03299322
Brief Title
A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Bronchial Asthma，TCM，microorganism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All treatment group received a standard anti-asthma treatment plus Jia Wei Yang He Formula on study entry, and the control group received Jia Wei Yang He Formula placebo instead.
Masking
ParticipantCare ProviderInvestigator
Masking Description
This is a Double-blind Trial
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
High dose Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Low dose Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Jia Wei Yang He granule
Other Intervention Name(s)
Jia Wei Yang He Formula
Intervention Description
This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time
Intervention Type
Drug
Intervention Name(s)
Jia Wei Yang He granule Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Made from 1/20 doses which has certain taste, but no therapeutic effect
Primary Outcome Measure Information:
Title
Asthma Control Test Score variation
Description
Measured the change from Baseline to the end of treatment
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Airway microbial diversity
Description
Measured by 16S rRNA sequencing of induces sputum
Time Frame
Baseline, 2 weeks and 4weeks
Title
Pulmonary function tests
Description
Measured the change from Baseline to the end of treatment
Time Frame
Baseline and 4 weeks
Title
Fractional exhaled nitric oxide (FeNO)
Description
Measured the change from Baseline to the end of treatment of exhaled nitric oxide
Time Frame
Baseline and 4 weeks
Title
Morning and evening Peak Expiratory Flow (PEF)
Description
Measured the change from Baseline to the end of treatment
Time Frame
Measured during the 4 weeks treatment period
Title
Cytokine levels of serum
Description
Measured the change from Baseline to the end of treatment
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zifeng Ma, Master
Phone
+8621-64385700
Ext
1307
Email
mzf05@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenhui Lu, Doctor
Phone
+8621-64385700
Ext
1307
Email
tcmdoctorlu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiyong Zhang, Master
Organizational Affiliation
Longhua Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Longhua Hospital Affiliated Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyou Fu, master
Phone
+8618917763366
Facility Name
Fengxian District traditional Chinese medicine hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donghua Zhou
Facility Name
Jingan district center hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huifang Cao
Facility Name
Pudong Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Bao
Facility Name
Shanghai eighth people's hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dejie Chu
Facility Name
Shanghai TCM-Integrated Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jia
Facility Name
Xuhui district center hospita
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronghuan Yu
Facility Name
Zhongshan Hospital affiliated fudan university
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changzhou Shao
12. IPD Sharing Statement
Citations:
PubMed Identifier
29973284
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma
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