AsthmaPhase 1NCT06650917
Acupoint Massage Combined With Ear Point Pressing Beans
A Phase 1 study testing the experiment group were treated acupoint massage combined with ear point pressing beans in people with Asthma, run by Hai'an Hospital of TCM001.
Trial summary
Objective: To explore the application effect of acupoint massage combined with ear point pressing beans in the remission stage of asthma. Methods: 120 children with asthma in remission who were treated in pediatric outpatient department from January 2016 to October 2022 were randomly divided into experimental group… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- the experiment group were treated acupoint massage combined with ear point pressing beans
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Dec 2022
- Phase
- Phase 1
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The patient met the diagnostic criteria of asthma remission in the Guidelines for prevention and treatment of bronchial asthma；
- 1~18 years old, course of disease > 1 year;
- Patients with complete clinical data and able to cooperate with treatment.
Who cannot join
- Patients with other cardiopulmonary system diseases or myasthenia gravis;
- Eczema, ulcer or other symptoms in the auricle or skin;
- Illiteracy, cognitive, language or communication disorders;
- The patient has taken medication for asthma treatment within 3 months.
About this study
Official title: Explore the Application Effect of Acupoint Massage Combined With Ear Point Pressing Beans in the Remission Stage of Asthma
Objective: To explore the application effect of acupoint massage combined with ear point pressing beans in the remission stage of asthma. Methods: 120 children with asthma in remission who were treated in pediatric outpatient department from January 2016 to October 2022 were randomly divided into experimental group and control group, with 60 cases in each group.The patients in both groups were treated with salmeterol and fluticasone inhalation powder once a day, twice a day. The patients in the control group were treated with acupoint massage on this basis. Acupoint massage once a day from Monday to Friday, lasting for 30 minutes each time.The patients in the experimental group were treated with ear point pressing beans on the basis of the control group. The ear point pressing beans is performed once a day from Monday to Friday. Changes in pulmonary function and asthma control were observed before and after treatment in the two groups were observed, and forced expiratory volume 1 second (FEV1),forced expiratory vital capacity (FVC), FEV1/FVC, asthma control test scale (ACT) score were compared.
- Conditions
- Asthma
- Being tested
- the experiment group were treated acupoint massage combined with ear point pressing beans, the control group were treated with acupoint massage
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the experiment group were treated acupoint massage combined with ear point pressing beansBehavioural
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation was used 1 puff each time, 2 times/d.
Patients in the experiment group were treated with auricular point pressing on basis if the treatment of the control group. Selecting 10 acupoints including Tanzhong, Tiantu, Dingchuan(both sides), Feishu(both sides), Yuji(both sides), and Lieque(both sides), and massage each acupoint for about 3 minutes. Acupoint massage once a day from Monday to Friday, lasting for 30 minutes each time. Selecting the Fengxi(both sides), Lung(both sides), Bronchial(both sides), and Shenmen(both sides) acupoints on the ear for ear point pressing beans. The operator rubs the above acupoints with their hands for about 5 minutes, and then performs ear point pressing beans on these 4 acupoints. The ear point pressing beans is performed once a day from Monday to Friday.
the control group were treated with acupoint massageBehavioural
Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation was used 1 puff each time, 2 times/d.
On this basis, patients in the control group were treated with acupoint massage.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | Not described Receives: Behavioral: the experiment group were treated acupoint massage combined with ear point pressing beans |
| control group | Active comparator | Not described Receives: Behavioral: the control group were treated with acupoint massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
Forced expiratory vital capacity (FVC), FEV 1 and FEV1/FVC ratio were measured with Jaeger pulmonary function testing instrument
Measured: 1 minutes
Asthma control
The Asthma Control test Scale (ACT) was used for assessment, including daily life status, dyspnea times, asthma symptoms, emergency medication use, and asthma control. Each item was 1 to 5 points, and the total score was 5 to 25 points.
Measured: 1 hour
Efficacy assessment
Complete control: no symptoms occurred throughout the day after treatment, no significant limitation of activity, no acute attack, PEF or FEV1 normal value or ≥ normal expected value; Partial control: after treatment, symptoms> 2 times/week during the day, wake up at night, mild limitation of activity. Drug relief is required for over 2 times/week; Uncontrolled: frequent symptoms during the day and at night, limited activity, acute attacks. Drugs should be used frequently for relief. Total control rate = complete control rate + partial control rate.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jan 2016
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hai'an Hospital of TCM001
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohong Chu, Hai'an Hospital of TCM001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650917
- Sponsor's protocol ID
- Hai'an Hospital of TCM001
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Application Effect of Acupoint Massage Combined With Ear Point Pressing Beans in the Remission Stage of Asthma
- ClinicalTrials.gov ID
- NCT06650917
- Acronym / sponsor ID
- Hai'an Hospital of TCM001
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hai'an Hospital of TCM001University, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Oct 2024 (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.
Objective: To explore the application effect of acupoint massage combined with ear point pressing beans in the remission stage of asthma. Methods: 120 children with asthma in remission who were treated in pediatric outpatient department from January 2016 to October 2022 were randomly divided into experimental group and control group, with 60 cases in each group.The patients in both groups were treated with salmeterol and fluticasone inhalation powder once a day, twice a day. The patients in the control group were treated with acupoint massage on this basis. Acupoint massage once a day from Monday to Friday, lasting for 30 minutes each time.The patients in the experimental group were treated with ear point pressing beans on the basis of the control group. The ear point pressing beans is performed once a day from Monday to Friday. Changes in pulmonary function and asthma control were observed before and after treatment in the two groups were observed, and forced expiratory volume 1 second (FEV1),forced expiratory vital capacity (FVC), FEV1/FVC, asthma control test scale (ACT) score were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Behavioral: the experiment group were treated acupoint massage combined with ear point pressing beans |
| control group | Active comparator | Behavioral: the control group were treated with acupoint massage |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- The patient met the diagnostic criteria of asthma remission in the Guidelines for prevention and treatment of bronchial asthma；
- 1~18 years old, course of disease > 1 year;
- Patients with complete clinical data and able to cooperate with treatment.
Key exclusion criteria (4 listed)
- Patients with other cardiopulmonary system diseases or myasthenia gravis;
- Eczema, ulcer or other symptoms in the auricle or skin;
- Illiteracy, cognitive, language or communication disorders;
- The patient has taken medication for asthma treatment within 3 months.
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 |
|---|---|---|
| the experiment group were treated acupoint massage combined with ear point pressing beansSalmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation was used 1 puff each time, 2 times/d. Patients in the experiment group were treated with auricular point pressing on basis if the treatment of the control group. Selecting 10 acupoints including Tanzhong, Tiantu, Dingchuan(both sides), Feishu(both sides), Yuji(both sides), and Lieque(both sides), and massage each acupoint for about 3 minutes. Acupoint massage once a day from Monday to Friday, lasting for 30 minutes each time. Selecting the Fengxi(both sides), Lung(both sides), Bronchial(both sides), and Shenmen(both sides) acupoints on the ear for ear point pressing beans. The operator rubs the above acupoints with their hands for about 5 minutes, and then performs ear point pressing beans on these 4 acupoints. The ear point pressing beans is performed once a day from Monday to Friday. | Behavioural | experiment group |
| the control group were treated with acupoint massageSalmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation was used 1 puff each time, 2 times/d. On this basis, patients in the control group were treated with acupoint massage. | Behavioural | control group |
Primary outcome
Pulmonary function
Time frame: 1 minutes
Forced expiratory vital capacity (FVC), FEV 1 and FEV1/FVC ratio were measured with Jaeger pulmonary function testing instrument
Asthma control
Time frame: 1 hour
The Asthma Control test Scale (ACT) was used for assessment, including daily life status, dyspnea times, asthma symptoms, emergency medication use, and asthma control. Each item was 1 to 5 points, and the total score was 5 to 25 points.
Efficacy assessment
Time frame: 1 hour
Complete control: no symptoms occurred throughout the day after treatment, no significant limitation of activity, no acute attack, PEF or FEV1 normal value or ≥ normal expected value; Partial control: after treatment, symptoms> 2 times/week during the day, wake up at night, mild limitation of activity. Drug relief is required for over 2 times/week; Uncontrolled: frequent symptoms during the day and at night, limited activity, acute attacks. Drugs should be used frequently for relief. Total control rate = complete control rate + partial control rate.
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 21 Oct 2024.
- 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.
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 1 study testing the experiment group were treated acupoint massage combined with ear point pressing beans in people with Asthma, run by Hai'an Hospital of TCM001.
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 3 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: finished, as of the sponsor's last update on 21 Oct 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pulmonary function (time frame: 1 minutes). 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 21 Oct 2024.