Bronchial AsthmaPhase 2NCT01293734
Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.
A Phase 2 study testing warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum, clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum and securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum in people with Bronchial Asthma, run by Liaoning University of Traditional Chinese Medicine.
Trial summary
Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese… 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?
- warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum, clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum and securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 2011
- 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
- Age between 18 to 65 years old;
- Patients with mild-to-moderate bronchial asthma on attacking stage;
- Without cardiopulmonary or other complications;
- To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;
- Informed consent form is required to be signed.
Who cannot join
- Older than 65 years or younger than 18 years old;
- Pregnant woman or suckling period woman;
- Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.
- Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;
- Irritable the physique, or allergic to the given composition of drugs in this research;
- Patients who are in the process of other clinical research.
About this study
Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.
- Conditions
- Bronchial Asthma
- Being tested
- warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum, clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum, securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum, Theophylline Sustained-release Tablets and budesonide suspension
- Keywords
- bronchial asthma, cold type, heat type, Asthenia type, TCM syndrome, symptoms, physical signs
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrumOther
warming lung and relieving asthmatic granule:once 1 bag, 3 times a day. Securing origin and warming lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrumOther
clearing lung and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and clearing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrumOther
securing origin and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and nourishing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
Theophylline Sustained-release Tablets and budesonide suspensionDrug
Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day
| Study group | Role | What they receive |
|---|---|---|
| cold type | Experimental | To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type Receives: Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum |
| heat type | Experimental | To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type. Receives: Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum |
| Asthenia type | Experimental | To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type. Receives: Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum |
| Western medicine control group | Active comparator | Not described Receives: Drug: Theophylline Sustained-release Tablets and budesonide suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary Symptom
Symptom: wheezing, cough, choking
Measured: 30 days
physical sign
physical sign: wheezing sound
Measured: 30 days
assistant examination
Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC
Measured: 30 days
Secondary outcomes (2)
Secondary Symptom
Symptom: expectoration, fever, Aversion to wind and cold
Measured: 30 days
physical sign
physical sign: tongue appearance and Pulse condition
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionFeb 2011
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
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaoning University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shenyang Huanggu District Central Hospital, Benxi City hospital of Chinese medicine, Anshan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293734
- Sponsor's protocol ID
- sygzwu
- Status last verified
- Jan 2011
- First submitted
- 10 Feb 2011
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.
- ClinicalTrials.gov ID
- NCT01293734
- Acronym / sponsor ID
- sygzwu
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, cold type, heat type, Asthenia type, TCM syndrome, symptoms, physical signs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Liaoning University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shenyang Huanggu District Central Hospital, Benxi City hospital of Chinese medicine, Anshan Central Hospital
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Feb 2011 (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.
Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cold type | Experimental | Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrumTo comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type |
| heat type | Experimental | Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrumTo comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type. |
| Asthenia type | Experimental | Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrumTo comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type. |
| Western medicine control group | Active comparator | Drug: Theophylline Sustained-release Tablets and budesonide suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 to 65 years old;
- Patients with mild-to-moderate bronchial asthma on attacking stage;
- Without cardiopulmonary or other complications;
- To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;
- Informed consent form is required to be signed.
Key exclusion criteria (6 listed)
- Older than 65 years or younger than 18 years old;
- Pregnant woman or suckling period woman;
- Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.
- Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;
- Irritable the physique, or allergic to the given composition of drugs in this research;
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 |
|---|---|---|
| warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrumwarming lung and relieving asthmatic granule:once 1 bag, 3 times a day. Securing origin and warming lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day | Other | cold type |
| clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrumclearing lung and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and clearing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day | Other | heat type |
| securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrumsecuring origin and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and nourishing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day | Other | Asthenia type |
| Theophylline Sustained-release Tablets and budesonide suspensionTheophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day | Drug | Western medicine control group |
Primary outcome
primary Symptom
Time frame: 30 days
Symptom: wheezing, cough, choking
physical sign
Time frame: 30 days
physical sign: wheezing sound
assistant examination
Time frame: 30 days
Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC
2 secondary outcomes
Secondary Symptom
Time frame: 30 days
physical sign
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum, clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum and securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum in people with Bronchial Asthma, run by Liaoning University of Traditional Chinese Medicine.
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: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
primary Symptom (time frame: 30 days). The study lists 3 primary outcomes in all. 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 11 Feb 2011.