Bronchial AsthmaNCT07632352
Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
A study testing Acupuncture and Standard Western medicine treatment in people with Bronchial Asthma, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Based on the bioholographic theory, this study preliminarily explores the clinical efficacy of hand acupuncture in treating acute exacerbation of bronchial asthma and evaluates its immediate anti-asthmatic effect, so as to provide a new therapeutic strategy for the clinical management of bronchial asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Acupuncture and Standard Western medicine treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting the Western medicine diagnostic criteria for acute exacerbation of bronchial asthma
- Aged ≥ 18 years old
- Voluntarily receive treatment and sign the informed consent form
Who cannot join
- Those who fail to meet the inclusion criteria
- Patients suffering from other severe systemic diseases such as diseases of the circulatory system, hematological system and nervous system
- Pregnant or lactating women
- Subjects enrolled but not treated per the study protocol
- Patients who have participated in other clinical trials of medicinal products within 3 months
- Other circumstances deemed ineligible for enrollment by researchers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000
Qinmei Yang, 15981845716, yangqinmei840105@126.com
About this study
Official title: Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma Based on Biological Holography Theory
Based on the bioholographic theory, this study preliminarily explores the clinical efficacy of hand acupuncture in treating acute exacerbation of bronchial asthma and evaluates its immediate anti-asthmatic effect, so as to provide a new therapeutic strategy for the clinical management of bronchial asthma.
Read the detailed description
This study adopted a randomized controlled trial design, with patients in the acute exacerbation phase of bronchial asthma as the research subjects. A total of 72 patients who met the inclusion criteria were randomly divided into the acupuncture group and the control group in a 1:1 ratio. The control group received standard Western medicine treatment, while the acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment. The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days, with a 3-month follow-up. The therapeutic efficacy of manual acupuncture in treating acute exacerbation of bronchial asthma was evaluated with indicators including symptom and sign scores, pulmonary function, ACT , mMRC , Mini-AQLQ scale, serum interleukin-4 (IL-4), serum eotaxin and specific immunoglobulin E (SIgE). In addition, the underlying therapeutic mechanism was preliminarily explored to formulate a technical protocol for rapid anti-asthma acupuncture, laying a foundation for long-term and objective efficacy evaluation of this therapy.
- Conditions
- Bronchial Asthma
- Being tested
- Acupuncture, Standard Western medicine treatment
- Keywords
- bronchial asthma, acute exacerbation, Biological holography theory, Acupuncture
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days.
Standard Western medicine treatmentDrug
Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | The acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment. The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days Receives: Other: Acupuncture; Drug: Standard Western medicine treatment |
| control group | Active comparator | The control group received standard Western medicine treatment Receives: Drug: Standard Western medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow(PEF)
PEF will be used to assess pulmonary function
Measured: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Asthma Control Test
The ACT score consists of 5 questions, each scored from 1 to 5 points, with a total score ranging from 5 to 25 points; lower scores indicate more severe symptoms.
Measured: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Secondary outcomes (7)
Forced expiratory volume in first second/pred（FEV1%pred）
FEV1%pred will be used to assess pulmonary function
Measured: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Clinical Symptom and Sign Score
It includes six symptoms: cough, expectoration, chest tightness, wheezing, shortness of breath and wheeze. Scores of 0, 3, 6 and 9 are assigned according to the severity of symptoms, with higher scores corresponding to more severe symptoms.
Measured: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Mini Asthma Quality of Life Questionnaire（Mini-AQLQ)
It consists of 15 questions, each scored on a scale from 1 to 7 based on the severity of symptoms and their degree of impact. A score of 1 indicates no symptoms or no adverse impacts, while a score of 7 stands for severe symptoms or substantial impairment. Lower total scores correspond to a higher quality of life.
Measured: After treatment on Day 5 and follow-up at 1, 2 and 3 months
modified Medical Research Council (mMRC)
Scores range from 0 to 4 based on the severity of dyspnea, with higher scores indicating more severe symptoms.
Measured: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Interleukin 4 (IL-4)
Detect the level of IL-4 in peripheral blood
Measured: After treatment on Day 5
Eotaxin
Detect the level of Eotaxin in peripheral blood
Measured: After treatment on Day 5
IgE
Detect the level of IgE in peripheral blood
Measured: After treatment on Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Apr 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion1 Jan 2027 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632352
- Sponsor's protocol ID
- TCM for BA
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma Based on Biological Holography Theory
- ClinicalTrials.gov ID
- NCT07632352
- Acronym / sponsor ID
- TCM for BA
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, acute exacerbation, Biological holography theory, Acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 8 Jun 2026 (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.
Based on the bioholographic theory, this study preliminarily explores the clinical efficacy of hand acupuncture in treating acute exacerbation of bronchial asthma and evaluates its immediate anti-asthmatic effect, so as to provide a new therapeutic strategy for the clinical management of bronchial asthma.
Detailed description
This study adopted a randomized controlled trial design, with patients in the acute exacerbation phase of bronchial asthma as the research subjects. A total of 72 patients who met the inclusion criteria were randomly divided into the acupuncture group and the control group in a 1:1 ratio. The control group received standard Western medicine treatment, while the acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment. The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days, with a 3-month follow-up. The therapeutic efficacy of manual acupuncture in treating acute exacerbation of bronchial asthma was evaluated with indicators including symptom and sign scores, pulmonary function, ACT , mMRC , Mini-AQLQ scale, serum interleukin-4 (IL-4), serum eotaxin and specific immunoglobulin E (SIgE). In addition, the underlying therapeutic mechanism was preliminarily explored to formulate a technical protocol for rapid anti-asthma acupuncture, laying a foundation for long-term and objective efficacy evaluation of this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Other: Acupuncture, Drug: Standard Western medicine treatmentThe acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment. The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days |
| control group | Active comparator | Drug: Standard Western medicine treatmentThe control group received standard Western medicine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients meeting the Western medicine diagnostic criteria for acute exacerbation of bronchial asthma
- Aged ≥ 18 years old
- Voluntarily receive treatment and sign the informed consent form
Key exclusion criteria (6 listed)
- Those who fail to meet the inclusion criteria
- Patients suffering from other severe systemic diseases such as diseases of the circulatory system, hematological system and nervous system
- Pregnant or lactating women
- Subjects enrolled but not treated per the study protocol
- Patients who have participated in other clinical trials of medicinal products 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 |
|---|---|---|
| AcupunctureThe acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days. | Other | acupuncture group |
| Standard Western medicine treatmentEvaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ). | Drug | acupuncture group, control group |
Primary outcome
Peak Expiratory Flow(PEF)
Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months
PEF will be used to assess pulmonary function
Asthma Control Test
Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months
The ACT score consists of 5 questions, each scored from 1 to 5 points, with a total score ranging from 5 to 25 points; lower scores indicate more severe symptoms.
7 secondary outcomes
Forced expiratory volume in first second/pred（FEV1%pred）
Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Clinical Symptom and Sign Score
Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Mini Asthma Quality of Life Questionnaire（Mini-AQLQ)
Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months
modified Medical Research Council (mMRC)
Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Interleukin 4 (IL-4)
Time frame: After treatment on Day 5
Eotaxin
Time frame: After treatment on Day 5
IgE
Time frame: After treatment on Day 5
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 8 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Standard Western medicine treatment in people with Bronchial Asthma, run by Henan University of Traditional Chinese Medicine at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Qinmei Yang (15981845716, yangqinmei840105@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow(PEF) (time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months). The study lists 2 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 8 Jun 2026.