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
1 other identifier
interventional
240
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2017
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 7, 2024
May 1, 2023
8.2 years
September 21, 2017
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma Control Test Score variation
Measured the change from Baseline to the end of treatment
Baseline and 4 weeks
Secondary Outcomes (5)
Airway microbial diversity
Baseline, 2 weeks and 4weeks
Pulmonary function tests
Baseline and 4 weeks
Fractional exhaled nitric oxide (FeNO)
Baseline and 4 weeks
Morning and evening Peak Expiratory Flow (PEF)
Measured during the 4 weeks treatment period
Cytokine levels of serum
Baseline and 4 weeks
Study Arms (3)
Control Group
PLACEBO COMPARATOR80 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.
High dose Treatment Group
EXPERIMENTALParticipants 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.
Low dose Treatment Group
EXPERIMENTALParticipants 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.
Interventions
This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time
Made from 1/20 doses which has certain taste, but no therapeutic effect
Eligibility Criteria
You may qualify if:
- Patient diagnosed with chronic persistent asthma
- Annual uncontrollable time ≥ 3 months
- Patients who have given written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032, China
Fengxian District traditional Chinese medicine hospital
Shanghai, China
Jingan district center hospital
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, China
Related Publications (1)
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.
PMID: 29973284DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huiyong Zhang, Master
Longhua Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- This is a Double-blind Trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2017
First Posted
October 3, 2017
Study Start
October 1, 2017
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
May 7, 2024
Record last verified: 2023-05