Bronchial AsthmaPhase 2NCT03228134
Clinical Study on Treatment of Chronic Persistent Bronchial Asthma
A Phase 2 study testing Ke Chuan Liu Wei Granule and Yang He Ping Chuan Granule in people with Bronchial Asthma, run by Shanghai University of Traditional Chinese Medicine at 5 sites in China.
Trial summary
Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of 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?
- Ke Chuan Liu Wei Granule and Yang He Ping Chuan Granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 5 sitesChina
- Study dates
- 1 Feb 2018to Sep 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
- Patient diagnosed with chronic persistent asthma
- Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- Conform to the predetermined 2 TCM Syndrome Types
- Patients who have given written informed consent
Who cannot join
- Smoking and continuous exposure to hazardous environment
- With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
- Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- Patients who are allergic to therapeutic medicine
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Fenglin Street Community Health Service Center
Shanghai, Shanghai Municipality, 200030
Chuntao Yi, Master, +8618817338803, yichuntao@126.com
- Not yet recruiting
Kangjian Street Community Health Service Center
Shanghai, Shanghai Municipality, 200030
Taiquan Huang, Master, +8613918375404, tqh957@sina.com.cn
- Not yet recruiting
Tianping Street Community Health Service Center
Shanghai, Shanghai Municipality, 200030
Xin He, Master, +8613501903509, hexin2050@163.com
- Recruiting
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Zifeng Ma, Master, +8618817338863, mzf05@126.com
- Recruiting
Fengxian District Hospital of TCM
Shanghai, Shanghai Municipality, 201400
Fang Fang, Master, +8613816856217, 13816856217@139.com
About this study
Official title: Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine
Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
Read the detailed description
The incidence of asthma in China is high and the rate of control is low. Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.
- Conditions
- Bronchial Asthma
- Being tested
- Ke Chuan Liu Wei Granule, Yang He Ping Chuan Granule, Ke Chuan Liu Wei Granule placebo, Yang He Ping Chuan Granule placebo
- Keywords
- treatment； bronchial asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ke Chuan Liu Wei GranuleDrug
Also called KCLW Granule
Traditional Chinese Medicine
Yang He Ping Chuan GranuleDrug
Also called YHPC Granule
Traditional Chinese Medicine
Ke Chuan Liu Wei Granule placeboOther
Also called Placebo
Placebo
Yang He Ping Chuan Granule placeboOther
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Hanxiao treatment group | Experimental | 80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist. Receives: Drug: Ke Chuan Liu Wei Granule |
| Hanxiao control group | Sham comparator | 80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist. Receives: Other: Ke Chuan Liu Wei Granule placebo |
| Xuxiao treatment group | Experimental | 80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist. Receives: Drug: Yang He Ping Chuan Granule |
| Xuxiao control group | Sham comparator | 80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist. Receives: Other: Yang He Ping Chuan Granule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control rate change
Measured the change from Baseline of asthma control rate
Measured: up to 4 weeks
Secondary outcomes (6)
Lung function(FEV1, PEF)
Measured routine pulmonary ventilation function test
Measured: Up to 4 weeks
FeNO
The fractional concentration of exhaled nitric oxide
Measured: Up to 4 weeks
Blood routine examination
Hematological routine examination
Measured: Up to 4 weeks
Liver function test
Simple liver function test
Measured: Up to 4 weeks
Cytokine levels of induced sputum
Measured cytokine levels of induced sputum supernatant
Measured: Up to 4 weeks
Kidney function test
Simple kidney function test
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Feb 2018
- Primary completionSep 2024 (estimated)
- Study completionSep 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
- All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital
- Responsible party
- Sponsor
- Investigators
- Huiyong Zhang, Director, Principal investigator, tcmdoctorzhang@163.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228134
- Sponsor's protocol ID
- 2017LCSY347
- Status last verified
- May 2023
- First submitted
- 17 Jul 2017
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT03228134
- Acronym / sponsor ID
- 2017LCSY347
- Conditions
- Bronchial Asthma
- Keywords
- treatment； bronchial asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Longhua Hospital
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 24 Jul 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 evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
Detailed description
The incidence of asthma in China is high and the rate of control is low. Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.
| Arm | Type | Receives |
|---|---|---|
| Hanxiao treatment group | Experimental | Drug: Ke Chuan Liu Wei Granule80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist. |
| Hanxiao control group | Sham comparator | Other: Ke Chuan Liu Wei Granule placebo80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist. |
| Xuxiao treatment group | Experimental | Drug: Yang He Ping Chuan Granule80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist. |
| Xuxiao control group | Sham comparator | Other: Yang He Ping Chuan Granule placebo80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with chronic persistent asthma
- Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- Conform to the predetermined 2 TCM Syndrome Types
- Patients who have given written informed consent
Key exclusion criteria (4 listed)
- Smoking and continuous exposure to hazardous environment
- With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
- Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- Patients who are allergic to therapeutic medicine
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 |
|---|---|---|
| Ke Chuan Liu Wei GranuleAlso: KCLW GranuleTraditional Chinese Medicine | Drug | Hanxiao treatment group |
| Yang He Ping Chuan GranuleAlso: YHPC GranuleTraditional Chinese Medicine | Drug | Xuxiao treatment group |
| Ke Chuan Liu Wei Granule placeboAlso: PlaceboPlacebo | Other | Hanxiao control group |
| Yang He Ping Chuan Granule placeboAlso: PlaceboPlacebo | Other | Xuxiao control group |
Primary outcome
Asthma control rate change
Time frame: up to 4 weeks
Measured the change from Baseline of asthma control rate
6 secondary outcomes
Lung function(FEV1, PEF)
Time frame: Up to 4 weeks
FeNO
Time frame: Up to 4 weeks
Blood routine examination
Time frame: Up to 4 weeks
Liver function test
Time frame: Up to 4 weeks
Cytokine levels of induced sputum
Time frame: Up to 4 weeks
Kidney function test
Time frame: Up to 4 weeks
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.
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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, Director principal investigator
tcmdoctorzhang@163.com
5 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 Ke Chuan Liu Wei Granule and Yang He Ping Chuan Granule in people with Bronchial Asthma, run by Shanghai University of Traditional Chinese Medicine at 5 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 4 inclusion and 4 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 5 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, Doctor (+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 rate change (time frame: up to 4 weeks). 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.