Bronchial AsthmaPhase 2NCT04522726
A Clinical Study on the Prevention of Mild to Moderate Intermittent Asthma With Chinese Medicine Weiyang Yuping Fang
A Phase 2 study testing Weiyang Yuping Fang in people with Bronchial Asthma, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Clinical exploring study of Weiyang Yuping Decoction in preventing acute attacks of mild to moderate intermittent asthma Based on the theory of "Preventing disease from exacerbating" in Chinese medicine. 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?
- Weiyang Yuping Fang
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Dec 2024
- 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
- Diagnosis of asthma according to GINA criteria with a documented history of at least 3 years prior to Visit 1
- Patients have asthma exacerbations every year
- Meet the diagnostic criteria for mild to moderate asthma
- Able to measure lung ventilation function according to ATS (American Thoracic Society) standards
- Patients who have given written informed consent
Who cannot join
- Medical history of life-threatening asthma including intubation and intensive care unit admission
- Any significant disease or disorder (e.g., cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
- Pregnancy, breast-feeding or planned pregnancy during the study.
- Participation in another clinical study or took other research drugs during the last 30 days prior to Visit 1
- Known or suspected hypersensitivity to study drugs or excipient
- Suspected poor capability, as judged by the investigator, of following instructions of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Clinical Exploring Study of Weiyang Yuping Decoction in Preventing Acute Attacks of Mild to Moderate Intermittent Asthma Based on the Theory of "Preventing Disease From Exacerbating" in Chinese Medicine
Clinical exploring study of Weiyang Yuping Decoction in preventing acute attacks of mild to moderate intermittent asthma Based on the theory of "Preventing disease from exacerbating" in Chinese medicine.
Read the detailed description
Based on the preliminary clinical and basic research, this project intends to highly optimize and integrate the TCM treatment of disease theory with the current methods to form two preventive treatment plans, one treatment group was given Weiyang Yupingfang Granules orally for 1 month on the "Sanfu"days and on the "Sanjiu" days each year for a total of 2 months one year; the other treatment group was given Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months one year.; Comparing the effect of prevention and treatment of mild to moderate intermittent asthma exacerbations of the two prevention methods , provides new ideas for the prevention and treatment of bronchial asthma in the future, and further improves bronchial The level of prevention and treatment of asthma.
- Conditions
- Bronchial Asthma
- Being tested
- Weiyang Yuping Fang
- Keywords
- bronchial asthma, Traditional Chinese Medicine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weiyang Yuping FangDrug
Also called Weiyang Yuping granules
Weiyang Yuping fang is a combination of the classic ancient Yuping dispersion used to prevent qi deficiency and susceptibility and Bushen Naqi granules optimized formated by Professor Shao Changrong's experience in treating chronic cough and asthma.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Treatment group A received Weiyang Yupingfang Granules orally for 1 month on the "Sanfu" days and on the"Sanjiu"days each year for a total of 2 months a year. Receives: Drug: Weiyang Yuping Fang |
| Treatment group B | Experimental | Treatment group A received Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months a year. Receives: Drug: Weiyang Yuping Fang |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual severe asthma exacerbation rate
Measured the change from Baseline of annual severe asthma exacerbation rate
Measured: up to 12 months after treatment
Secondary outcomes (4)
Time to first severe asthma exacerbation
Record the time of the patient's first severe asthma exacerbation after treatment
Measured: up to 12 months after treatment
Average change from baseline in pre-dose FEV1
Measured the change from Baseline of forced expiratory volume in the first second
Measured: up to 24 months
Average change from baseline in pre-dose PEF
Measured the change from Baseline of peak expiratory flow
Measured: up to 24 months
Average change from baseline in Asthma Control Questionnaire
Measured the change from Baseline of Asthma Control Questionnaire (5-item version) - ACQ-5 score
Measured: up to 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- One group was given Weiyang Yupingfang Granules orally for 1 month on the "Sanfu"days and on the "Sanjiu" days each year for a total of 2 months one year; the other group was given Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months one year.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenhui Lu, Doctor, Study chair, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522726
- Sponsor's protocol ID
- 2020LHSB022
- Status last verified
- Mar 2023
- First submitted
- 19 Aug 2020
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Exploring Study of Weiyang Yuping Decoction in Preventing Acute Attacks of Mild to Moderate Intermittent Asthma Based on the Theory of "Preventing Disease From Exacerbating" in Chinese Medicine
- ClinicalTrials.gov ID
- NCT04522726
- Acronym / sponsor ID
- 2020LHSB022
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Aug 2020 (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.
Clinical exploring study of Weiyang Yuping Decoction in preventing acute attacks of mild to moderate intermittent asthma Based on the theory of "Preventing disease from exacerbating" in Chinese medicine.
Detailed description
Based on the preliminary clinical and basic research, this project intends to highly optimize and integrate the TCM treatment of disease theory with the current methods to form two preventive treatment plans, one treatment group was given Weiyang Yupingfang Granules orally for 1 month on the "Sanfu"days and on the "Sanjiu" days each year for a total of 2 months one year; the other treatment group was given Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months one year.; Comparing the effect of prevention and treatment of mild to moderate intermittent asthma exacerbations of the two prevention methods , provides new ideas for the prevention and treatment of bronchial asthma in the future, and further improves bronchial The level of prevention and treatment of asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- One group was given Weiyang Yupingfang Granules orally for 1 month on the "Sanfu"days and on the "Sanjiu" days each year for a total of 2 months one year; the other group was given Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months one year.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: Weiyang Yuping FangTreatment group A received Weiyang Yupingfang Granules orally for 1 month on the "Sanfu" days and on the"Sanjiu"days each year for a total of 2 months a year. |
| Treatment group B | Experimental | Drug: Weiyang Yuping FangTreatment group A received Weiyang Yupingfang Granules orally for 1 month in the first month of each quarter in the four quarters of the year, for a total of 4 months a year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of asthma according to GINA criteria with a documented history of at least 3 years prior to Visit 1
- Patients have asthma exacerbations every year
- Meet the diagnostic criteria for mild to moderate asthma
- Able to measure lung ventilation function according to ATS (American Thoracic Society) standards
- Patients who have given written informed consent
Key exclusion criteria (6 listed)
- Medical history of life-threatening asthma including intubation and intensive care unit admission
- Any significant disease or disorder (e.g., cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
- Pregnancy, breast-feeding or planned pregnancy during the study.
- Participation in another clinical study or took other research drugs during the last 30 days prior to Visit 1
- Known or suspected hypersensitivity to study drugs or excipient
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 |
|---|---|---|
| Weiyang Yuping FangAlso: Weiyang Yuping granulesWeiyang Yuping fang is a combination of the classic ancient Yuping dispersion used to prevent qi deficiency and susceptibility and Bushen Naqi granules optimized formated by Professor Shao Changrong's experience in treating chronic cough and asthma. | Drug | Treatment group A, Treatment group B |
Primary outcome
Annual severe asthma exacerbation rate
Time frame: up to 12 months after treatment
Measured the change from Baseline of annual severe asthma exacerbation rate
4 secondary outcomes
Time to first severe asthma exacerbation
Time frame: up to 12 months after treatment
Average change from baseline in pre-dose FEV1
Time frame: up to 24 months
Average change from baseline in pre-dose PEF
Time frame: up to 24 months
Average change from baseline in Asthma Control Questionnaire
Time frame: up to 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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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.
Zhenhui Lu, Doctor study chair
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Weiyang Yuping Fang in people with Bronchial Asthma, run by Shanghai University of Traditional Chinese Medicine at 1 site 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 5 inclusion and 6 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 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual severe asthma exacerbation rate (time frame: up to 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2023.