Bronchial AsthmaPhase 2NCT03299322
A Study to Assess Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma
A Phase 2 study testing Jia Wei Yang He granule in people with Bronchial Asthma, run by Shanghai University of Traditional Chinese Medicine at 8 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Jia Wei Yang He granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 8 sitesChina
- Study dates
- 1 Oct 2017to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with chronic persistent asthma
- Annual uncontrollable time ≥ 3 months
- Patients who have given written informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Jiyou Fu, master, +8618917763366
- Not yet recruiting
Fengxian District traditional Chinese medicine hospital
Shanghai
Donghua Zhou
- Not yet recruiting
Jingan district center hospital
Shanghai
Huifang Cao
- Not yet recruiting
Pudong Hospital
Shanghai
Hong Bao
- Not yet recruiting
Shanghai eighth people's hospital
Shanghai
Dejie Chu
- Not yet recruiting
Shanghai TCM-Integrated Hospital
Shanghai
Wei Jia
- Not yet recruiting
Xuhui district center hospita
Shanghai
Ronghuan Yu
- Not yet recruiting
Zhongshan Hospital affiliated fudan university
Shanghai
Changzhou Shao
About this study
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
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
Read the 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
- Being tested
- Jia Wei Yang He granule, Jia Wei Yang He granule Placebo
- Keywords
- Bronchial Asthma，TCM，microorganism
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jia Wei Yang He granuleDrug
Also called Jia Wei Yang He Formula
This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time
Jia Wei Yang He granule PlaceboDrug
Also called Placebo
Made from 1/20 doses which has certain taste, but no therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 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. Receives: Drug: Jia Wei Yang He granule Placebo |
| High dose Treatment Group | Experimental | 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. Receives: Drug: Jia Wei Yang He granule |
| Low dose Treatment Group | Experimental | 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. Receives: Drug: Jia Wei Yang He granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test Score variation
Measured the change from Baseline to the end of treatment
Measured: Baseline and 4 weeks
Secondary outcomes (5)
Airway microbial diversity
Measured by 16S rRNA sequencing of induces sputum
Measured: Baseline, 2 weeks and 4weeks
Pulmonary function tests
Measured the change from Baseline to the end of treatment
Measured: Baseline and 4 weeks
Fractional exhaled nitric oxide (FeNO)
Measured the change from Baseline to the end of treatment of exhaled nitric oxide
Measured: Baseline and 4 weeks
Morning and evening Peak Expiratory Flow (PEF)
Measured the change from Baseline to the end of treatment
Measured: Measured during the 4 weeks treatment period
Cytokine levels of serum
Measured the change from Baseline to the end of treatment
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Huiyong Zhang, Master, Study chair, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299322
- Sponsor's protocol ID
- 2016LCSY098
- Status last verified
- May 2023
- First submitted
- 21 Sep 2017
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29973284
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03299322
- Acronym / sponsor ID
- 2016LCSY098
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial Asthma，TCM，microorganism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Jia Wei Yang He granule Placebo80 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 | Experimental | Drug: Jia Wei Yang He granuleParticipants 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 | Experimental | Drug: Jia Wei Yang He granuleParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient diagnosed with chronic persistent asthma
- Annual uncontrollable time ≥ 3 months
- Patients who have given written informed consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jia Wei Yang He granuleAlso: Jia Wei Yang He FormulaThis is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time | Drug | High dose Treatment Group, Low dose Treatment Group |
| Jia Wei Yang He granule PlaceboAlso: PlaceboMade from 1/20 doses which has certain taste, but no therapeutic effect | Drug | Control Group |
Primary outcome
Asthma Control Test Score variation
Time frame: Baseline and 4 weeks
Measured the change from Baseline to the end of treatment
5 secondary outcomes
Airway microbial diversity
Time frame: Baseline, 2 weeks and 4weeks
Pulmonary function tests
Time frame: Baseline and 4 weeks
Fractional exhaled nitric oxide (FeNO)
Time frame: Baseline and 4 weeks
Morning and evening Peak Expiratory Flow (PEF)
Time frame: Measured during the 4 weeks treatment period
Cytokine levels of serum
Time frame: Baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 29973284Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiyong Zhang, Master study chair
Longhua Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Jia Wei Yang He granule in people with Bronchial Asthma, run by Shanghai University of Traditional Chinese Medicine at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zifeng Ma, Master (+8621-64385700 ext. 1307, mzf05@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test Score variation (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.