AsthmaNCT06777472
Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma
A study testing lung-benefiting moxibustion and The specific drug comes from "GINA (2024)" in people with Asthma, run by Cuiling Feng.
Trial summary
For patients with poor asthma control, on the basis of treatment guided by GINA guidelines, lung-benefiting moxibustion treatment will be given, and it will be applied 10 days before "early onset", once every 10 days, and the follow-up was 45 weeks, 1 cycle per year, for 2 consecutive cycles (2 years). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- lung-benefiting moxibustion and The specific drug comes from "GINA (2024)"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnosis of asthma (remission);
- Patients with poor clinical control;
- Age 18-80 years old;
- Voluntarily undergo treatment and sign an informed consent form;
Who cannot join
- Patients combined with pulmonary abscess, pulmonary fibrosis, active pulmonary tuberculosis, bronchiectasis or other lung diseases;
- Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, cardiac functional classification≥III, stroke, cerebral hemorrhage, etc.)；
- Patients with severe liver diseases (liver cirrhosis, portal hypertension, bleeding due to esophageal and gastric varices, etc.) or severe kidney diseases (renal dialysis, kidney transplantation, etc.)；
- Patients with confusion, various mental disorders, etc., who are unable to communicate normally;
- Pregnant and lactating women;
- Patients with heat phlegm pattern through TCM pattern differentiation；
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- Patients participating in other clinical trials within 1 month prior to enrollment;
- Received TCM external treatment such as lung-benefiting moxibustion for 1 year;
- Patients allergic to moxibustion drugs, smoke, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on Reducing Exacerbations of Asthma by Lung-benefiting Moxibustion Based on "Winter Disease Cured in Summer"
For patients with poor asthma control, on the basis of treatment guided by GINA guidelines, lung-benefiting moxibustion treatment will be given, and it will be applied 10 days before "early onset", once every 10 days, and the follow-up was 45 weeks, 1 cycle per year, for 2 consecutive cycles (2 years). The annual number of flare-up of asthma patients will be used as the main outcome index to evaluate the clinical effect of lung-benefiting moxibustion on reducing exacerbations of asthma. By observing immunoglobulin, T cell subsets and other indicators, the advantage population and mechanism of moxibustion in treating patients with poor asthma control will be clarified.
- Conditions
- Asthma
- Being tested
- lung-benefiting moxibustion, The specific drug comes from "GINA (2024)"
- Keywords
- asthma out of control, lung-benefiting moxibustion, Treating winter diseases in summer, RCT
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung-benefiting moxibustionOther
A kind of external treatment，the treatment theory is to treat winter diseases in summer.
The specific drug comes from "GINA (2024)"Drug
Refer to "GINA (2024)".
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows：
1. The procedure of moxibustion includes 13 steps: selecting the body position, choosing the point, disinfecting, applying ginger juice, sprinkling moxibustion powder, covering mulberry paper, laying ginger mud, placing moxa cone, lighting moxa cone, changing moxa cone, removing ginger mud, gently rubbing moxibustion spot and placing blisters; The time of each application of moxibustion is 90 minutes.
2. Treatment course: Start 10 days before the "early onset", once every 10 days, intervene 5 times, 1 year as one cycle, 2 consecutive cycles. Receives: Other: lung-benefiting moxibustion; Drug: The specific drug comes from "GINA (2024)" |
| control group | Active comparator | Refer to "GINA (2024)". Regulations on combined medication: When complications occur during treatment, symptomatic treatment can be given according to the clinical situation. At the same time, the name, manufacturer, batch number, usage, dosage, course of treatment, etc. of the drug should be recorded in detail. Receives: Drug: The specific drug comes from "GINA (2024)" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual number of flare-up of asthma
Frequency
Measured: 1year
Secondary outcomes (5)
ACT and ACQ questionnaires
- ACT asthma control test A score of 25 indicates well-controlled asthma, 20-24 indicates partially controlled asthma, and 20 indicates uncontrolled.
- Asthma Control Questionnaire <0.75 points indicates that asthma is completely controlled: 0.75-1.5 points indicates good control of asthma: >.15 points indicates that asthma is not well controlled
Measured: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.
AQLQ scale
Asthma Quality of Life Questionnaire When calculating the overall score, the scores of each dimension are averaged to obtain a score between 0 and 7. The higher the score, worse the patient's quality of life. According to the AQLQ scoring criteria, a score above 5 indicates a relatively good quality of life, while a below 3 indicates a poor quality of life.
Measured: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.
Pulmonary ventilation test and Diastolic test
Ventilation function test ml
Measured: Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment.
FeNO
The fractional concentration of exhaled nitric oxide
Measured: Before treatment,and at 52, 104 weeks.
Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets
EO# x 10^9/L Ig E IU/mL percent of CD4+ cell、CD8+ cell 、CD4+/CD8+ cell
Measured: Before treatment,and at 7, 52, 59, 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startJul 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cuiling Feng
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Sponsor-investigator, Cuiling Feng, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777472
- Sponsor's protocol ID
- 2024PHB342-001
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: have not decided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Reducing Exacerbations of Asthma by Lung-benefiting Moxibustion Based on "Winter Disease Cured in Summer"
- ClinicalTrials.gov ID
- NCT06777472
- Acronym / sponsor ID
- 2024PHB342-001
- Conditions
- Asthma
- Keywords
- asthma out of control, lung-benefiting moxibustion, Treating winter diseases in summer, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Cuiling FengUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- Jul 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jan 2025 (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.
For patients with poor asthma control, on the basis of treatment guided by GINA guidelines, lung-benefiting moxibustion treatment will be given, and it will be applied 10 days before "early onset", once every 10 days, and the follow-up was 45 weeks, 1 cycle per year, for 2 consecutive cycles (2 years). The annual number of flare-up of asthma patients will be used as the main outcome index to evaluate the clinical effect of lung-benefiting moxibustion on reducing exacerbations of asthma. By observing immunoglobulin, T cell subsets and other indicators, the advantage population and mechanism of moxibustion in treating patients with poor asthma control will be clarified.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Other: lung-benefiting moxibustion, Drug: The specific drug comes from "GINA (2024)"On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows： 1. The procedure of moxibustion includes 13 steps: selecting the body position, choosing the point, disinfecting, applying ginger juice, sprinkling moxibustion powder, covering mulberry paper, laying ginger mud, placing moxa cone, lighting moxa cone, changing moxa cone, removing ginger mud, gently rubbing moxibustion spot and placing blisters; The time of each application of moxibustion is 90 minutes. 2. Treatment course: Start 10 days before the "early onset", once every 10 days, intervene 5 times, 1 year as one cycle, 2 consecutive cycles. |
| control group | Active comparator | Drug: The specific drug comes from "GINA (2024)"Refer to "GINA (2024)". Regulations on combined medication: When complications occur during treatment, symptomatic treatment can be given according to the clinical situation. At the same time, the name, manufacturer, batch number, usage, dosage, course of treatment, etc. of the drug should be recorded in detail. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who meet the diagnosis of asthma (remission);
- Patients with poor clinical control;
- Age 18-80 years old;
- Voluntarily undergo treatment and sign an informed consent form;
Key exclusion criteria (9 listed)
- Patients combined with pulmonary abscess, pulmonary fibrosis, active pulmonary tuberculosis, bronchiectasis or other lung diseases;
- Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, cardiac functional classification≥III, stroke, cerebral hemorrhage, etc.)；
- Patients with severe liver diseases (liver cirrhosis, portal hypertension, bleeding due to esophageal and gastric varices, etc.) or severe kidney diseases (renal dialysis, kidney transplantation, etc.)；
- Patients with confusion, various mental disorders, etc., who are unable to communicate normally;
- Pregnant and lactating women;
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 |
|---|---|---|
| lung-benefiting moxibustionA kind of external treatment，the treatment theory is to treat winter diseases in summer. | Other | test group |
| The specific drug comes from "GINA (2024)"Refer to "GINA (2024)". | Drug | control group, test group |
Primary outcome
Annual number of flare-up of asthma
Time frame: 1year
Frequency
5 secondary outcomes
ACT and ACQ questionnaires
Time frame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.
AQLQ scale
Time frame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.
Pulmonary ventilation test and Diastolic test
Time frame: Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment.
FeNO
Time frame: Before treatment,and at 52, 104 weeks.
Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets
Time frame: Before treatment,and at 7, 52, 59, 104 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided. have not decided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing lung-benefiting moxibustion and The specific drug comes from "GINA (2024)" in people with Asthma, run by Cuiling Feng.
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 9 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: opening soon, as of the sponsor's last update on 15 Jan 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact C Feng (010-88325882, fengcuiling@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual number of flare-up of asthma (time frame: 1year). 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 15 Jan 2025.