Bronchial AsthmaPhase 2NCT02937207
Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
A Phase 2 study testing Ke Chuan Liu Wei Mixture, Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule in people with Bronchial Asthma, run by Shanghai University of Traditional Chinese Medicine at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to promote the application in community hospitals. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Ke Chuan Liu Wei Mixture, Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 5 sitesChina
- Study dates
- 30 Jul 2017to Dec 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- Number of months without control between 1 and 3 months last year
- The course of asthma was more than 10 years and less than 30 years
- Conform to the predetermined 4 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.
- Long term inhaled corticosteroids (more than 5 years) prior to study entry
- Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- Rheumatic immune disease, diabetes, hyperthyroidism, menopause, gastroesophageal reflux, arrhythmia and other complications of the disease
- Heart, liver, kidney and other organ dysfunction
Show all 10Show fewer
- Accompanied by other diseases of long-term use of glucocorticoids, anti allergy drugs, mental or neurological drugs or traditional Chinese Medicine
- Patients who are allergic to therapeutic medicine
- Female patients in lactation period, pregnancy or planning to get pregnant during the trial
- Patients with mental or neurological disorders
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet 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
- Not yet recruiting
Fengxian District Hospital of TCM
Shanghai, Shanghai Municipality, 201400
Fang Fang, Master, +8613816856217, 13816856217@139.com
About this study
The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to promote the application in community hospitals.
Read the detailed description
Asthma is a serious global health problem and has increasing prevalence in many countries.Although asthma symptoms can be controlled by drug treatment to a large extent, there is still inadequate.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 promote the application in community hospitals. This could constitute a significant advance in asthma management.
In this study, the investigators recruited patients with asthma exacerbation and remission stage, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program.Participants will undergo a physical examination, lung function, blood and sputum collection.
Exacerbation group belongs to cold type of asthma patients will take Ke Chuan Liu Wei Mixture, wind phlegm type of asthma patients will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule，and hot type of asthma patients will take Dan Ma Jia Tablet for 14 days treatment, while the 3 control groups were given 3 corresponding placebo treatment for a total of 14 days.
Remission phase of Yang deficiency patients in treatment group will take Zhi Chuan Capsule and Bu Shen Na Qi Granule, and in control group received a placebo treatment for a total of 60 days.
Study visits will occur for 7 days of exacerbation group and 1 year for remission group. Questionnaires to assess asthma control will be completed during study of asthma at exacerbation stage within 44 days and on remission period within 12 months.
- Conditions
- Bronchial Asthma
- Being tested
- Ke Chuan Liu Wei Mixture, Chuan Xiong Ping Chuan Mixture, Xie Wu Capsule, Dan Ma Jia Tablet, Zhi Chuan Capsule
- 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.
Ke Chuan Liu Wei MixtureDrug
Also called Ke Chuan Liu Wei He Ji
Experience formula of famous traditional Chinese professor Yingen Wu
Chuan Xiong Ping Chuan MixtureDrug
Also called Chuan Xiong Ping Chuan He Ji
Experience formula of famous traditional Chinese professor Changrong Shao
Xie Wu CapsuleDrug
Also called Xie Wu Jiao Nang
Experience formula of famous traditional Chinese professor Jianhua Hu
Dan Ma Jia TabletDrug
Also called Dan Ma Jia Pian
Experience formula of famous traditional Chinese professor Xiaopu Xu
Zhi Chuan CapsuleDrug
Also called Zhi Chuan Jiao Nang
Experience formula of famous traditional Chinese professor Yingen Wu
Bu Shen Na Qi GranuleDrug
Also called Bu Shen Na Qi Ke Li
Experience formula of famous traditional Chinese professor Changrong Shao
Ke Chuan Liu Wei Mixture placeboDrug
Also called placebo
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
Chuan Xiong Ping Chuan Mixture placeboDrug
Also called placebo
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
Xie Wu Capsule placeboDrug
Also called placebo
Low dose combination for treating prescription of Xie Wu Capsule
Dan Ma Jia Tablet placeboDrug
Also called placebo
Low dose combination for treating prescription of Dan Ma Jia Tablet
Zhi Chuan Capsule placeboDrug
Also called placebo
Low dose combination for treating prescription of Zhi Chuan Capsule
Bu Shen Na Qi Granule placeboDrug
Also called placebo
Low dose combination for treating prescription of Bu Shen Na Qi Granule
| Study group | Role | What they receive |
|---|---|---|
| Hanxiao treatment group | Experimental | 36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Ke Chuan Liu Wei Mixture |
| Hanxiao control group | Placebo comparator | 36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Ke Chuan Liu Wei Mixture placebo |
| Fengtanxiao treatment group | Experimental | 36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Chuan Xiong Ping Chuan Mixture; Drug: Xie Wu Capsule |
| Fengtanxiao control group | Placebo comparator | 36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture placebo and Xie Wu Capsule placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Chuan Xiong Ping Chuan Mixture placebo; Drug: Xie Wu Capsule placebo |
| Rexiao treatment group | Experimental | 36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Dan Ma Jia Tablet |
| Rexiao control group | Placebo comparator | 36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Dan Ma Jia Tablet placebo |
| Xuxiao treatment group | Experimental | 36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule and Bu Shen Na Qi Granule oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Zhi Chuan Capsule; Drug: Bu Shen Na Qi Granule |
| Xuxiao control group | Placebo comparator | 36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule placebo and Bu Shen Na Qi Granule placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. Receives: Drug: Zhi Chuan Capsule placebo; Drug: Bu Shen Na Qi Granule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control rate
Asthma control rate will be measured during study of asthma at exacerbation stage within 44 days and symptom-free months will be measured on remission period within 12 months
Measured: up to 12 months
Secondary outcomes (8)
Lung function(FEV1, PVC, PEF)
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Measured: up to 12 months
Measurement of the fractional concentration of exhaled nitric oxide
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Measured: up to 12 months
Blood routine examination
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Measured: up to 12 months
Cytokine levels of serum and induced sputum
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Measured: up to 12 months
Liver function test
Measured Liver function
Measured: up to 12 months
Kidney function test
Measured Kidney function
Measured: up to 12 months
T cell classification
Measured T cell classification of PBMC
Measured: up to 12 months
Cytokine levels of induced sputum
Measured cytokine levels of induced sputum supernatant
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start30 Jul 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 288 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, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937207
- Sponsor's protocol ID
- LH20161013
- Status last verified
- Dec 2019
- First submitted
- 14 Oct 2016
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Through this study, to find the appropriate treatment of traditional Chinese medicine, then to further promote
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT02937207
- Acronym / sponsor ID
- LH20161013
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial Asthma, Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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.
The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to promote the application in community hospitals.
Detailed description
Asthma is a serious global health problem and has increasing prevalence in many countries.Although asthma symptoms can be controlled by drug treatment to a large extent, there is still inadequate.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 promote the application in community hospitals. This could constitute a significant advance in asthma management.
In this study, the investigators recruited patients with asthma exacerbation and remission stage, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program.Participants will undergo a physical examination, lung function, blood and sputum collection.
Exacerbation group belongs to cold type of asthma patients will take Ke Chuan Liu Wei Mixture, wind phlegm type of asthma patients will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule，and hot type of asthma patients will take Dan Ma Jia Tablet for 14 days treatment, while the 3 control groups were given 3 corresponding placebo treatment for a total of 14 days.
Remission phase of Yang deficiency patients in treatment group will take Zhi Chuan Capsule and Bu Shen Na Qi Granule, and in control group received a placebo treatment for a total of 60 days.
Study visits will occur for 7 days of exacerbation group and 1 year for remission group. Questionnaires to assess asthma control will be completed during study of asthma at exacerbation stage within 44 days and on remission period within 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Hanxiao treatment group | Experimental | Drug: Ke Chuan Liu Wei Mixture36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. |
| Hanxiao control group | Placebo comparator | Drug: Ke Chuan Liu Wei Mixture placebo36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. |
| Fengtanxiao treatment group | Experimental | Drug: Chuan Xiong Ping Chuan Mixture, Drug: Xie Wu Capsule36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. |
| Fengtanxiao control group | Placebo comparator | Drug: Chuan Xiong Ping Chuan Mixture placebo, Drug: Xie Wu Capsule placebo36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture placebo and Xie Wu Capsule placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist. |
| Rexiao treatment group | Experimental | Drug: Dan Ma Jia Tablet36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. |
| Rexiao control group | Placebo comparator | Drug: Dan Ma Jia Tablet placebo36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. |
| Xuxiao treatment group | Experimental | Drug: Zhi Chuan Capsule, Drug: Bu Shen Na Qi Granule36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule and Bu Shen Na Qi Granule oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. |
| Xuxiao control group | Placebo comparator | Drug: Zhi Chuan Capsule placebo, Drug: Bu Shen Na Qi Granule placebo36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule placebo and Bu Shen Na Qi Granule placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- Number of months without control between 1 and 3 months last year
- The course of asthma was more than 10 years and less than 30 years
- Conform to the predetermined 4 TCM Syndrome Types
- Patients who have given written informed consent
Key exclusion criteria (10 listed)
- Smoking and continuous exposure to hazardous environment
- With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
- Long term inhaled corticosteroids (more than 5 years) prior to study entry
- Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- Rheumatic immune disease, diabetes, hyperthyroidism, menopause, gastroesophageal reflux, arrhythmia and other complications of the disease
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 MixtureAlso: Ke Chuan Liu Wei He JiExperience formula of famous traditional Chinese professor Yingen Wu | Drug | Hanxiao treatment group |
| Chuan Xiong Ping Chuan MixtureAlso: Chuan Xiong Ping Chuan He JiExperience formula of famous traditional Chinese professor Changrong Shao | Drug | Fengtanxiao treatment group |
| Xie Wu CapsuleAlso: Xie Wu Jiao NangExperience formula of famous traditional Chinese professor Jianhua Hu | Drug | Fengtanxiao treatment group |
| Dan Ma Jia TabletAlso: Dan Ma Jia PianExperience formula of famous traditional Chinese professor Xiaopu Xu | Drug | Rexiao treatment group |
| Zhi Chuan CapsuleAlso: Zhi Chuan Jiao NangExperience formula of famous traditional Chinese professor Yingen Wu | Drug | Xuxiao treatment group |
| Bu Shen Na Qi GranuleAlso: Bu Shen Na Qi Ke LiExperience formula of famous traditional Chinese professor Changrong Shao | Drug | Xuxiao treatment group |
| Ke Chuan Liu Wei Mixture placeboAlso: placeboLow dose combination for treating prescription of Ke Chuan Liu Wei Mixture | Drug | Hanxiao control group |
| Chuan Xiong Ping Chuan Mixture placeboAlso: placeboLow dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture | Drug | Fengtanxiao control group |
| Xie Wu Capsule placeboAlso: placeboLow dose combination for treating prescription of Xie Wu Capsule | Drug | Fengtanxiao control group |
| Dan Ma Jia Tablet placeboAlso: placeboLow dose combination for treating prescription of Dan Ma Jia Tablet | Drug | Rexiao control group |
| Zhi Chuan Capsule placeboAlso: placeboLow dose combination for treating prescription of Zhi Chuan Capsule | Drug | Xuxiao control group |
| Bu Shen Na Qi Granule placeboAlso: placeboLow dose combination for treating prescription of Bu Shen Na Qi Granule | Drug | Xuxiao control group |
Primary outcome
Asthma control rate
Time frame: up to 12 months
Asthma control rate will be measured during study of asthma at exacerbation stage within 44 days and symptom-free months will be measured on remission period within 12 months
8 secondary outcomes
Lung function(FEV1, PVC, PEF)
Time frame: up to 12 months
Measurement of the fractional concentration of exhaled nitric oxide
Time frame: up to 12 months
Blood routine examination
Time frame: up to 12 months
Cytokine levels of serum and induced sputum
Time frame: up to 12 months
Liver function test
Time frame: up to 12 months
Kidney function test
Time frame: up to 12 months
T cell classification
Time frame: up to 12 months
Cytokine levels of induced sputum
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: Undecided. Through this study, to find the appropriate treatment of traditional Chinese medicine, then to further promote
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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
Longhua Hospital
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 Mixture, Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule 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 5 inclusion and 10 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 26 Feb 2020. 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, Master (+8602164385700 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 (time frame: up to 12 months). 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 26 Feb 2020.