Asthma ChronicNCT07611955
A Study of Acupuncture for Treating Asthma
A study testing Acupuncture in people with Asthma Chronic and Asthma (Diagnosis), run by Shanghai University of Traditional Chinese Medicine.
Trial summary
Asthma is a common chronic respiratory disease with a low clinical control rate, highlighting the need for novel therapeutic strategies. Recurrent asthma attacks emotional symptoms, such as anxiety and depression, etc. On the contrary, symptoms such as anxiety and depression worsen asthma control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma Chronic, Asthma (Diagnosis), Asthma
- What is being tested?
- Acupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2026to Sep 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for asthma, and be in the chronic persistent phase with mild to moderate disease severity, referring to the grading criteria of the Guidelines for the Prevention and Treatment of Asthma (2024 Edition).
- Aged 18 to 70 years, regardless of gender.
- Asthma Control Test (ACT) score≤19 points (poorly controlled or very poorly controlled asthma).
- Maintain a stable asthma treatment regimen for at least 4 weeks before enrollment.
- Clear thinking and consciousness, coherent responses, able to understand the items of various scales and complete the assessment.
- Volunteer to participate in this study and sign a written informed consent form.
Who cannot join
- Complicated with severe mental illnesses (such as uncontrolled schizophrenia, acute phase of bipolar disorder, etc.) or moderate to severe cognitive impairment (such as dementia), resulting in inability to understand the research process or cooperate with efficacy evaluation.
- A history of substance/alcohol dependence within the past 12 months.
- Complicated with other physical diseases that may cause depressive symptoms (such as hypothyroidism, chronic pain syndrome, malignant tumors, rheumatoid arthritis, etc.).
- Received antidepressant drug treatment within the past 6 months.
- Suffering from other respiratory diseases, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, etc.
- Complicated with other cancers or relatively severe chronic diseases of the heart, liver, kidneys, etc.
- Received acupuncture treatment within the past 3 months.
- Pregnant or lactating women.
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: The Effects of Acupuncture on Patients With Chronic Asthma: a Multicenter, Randomized, Three-arm, Sham-controlled Superiority Trial
Asthma is a common chronic respiratory disease with a low clinical control rate, highlighting the need for novel therapeutic strategies. Recurrent asthma attacks emotional symptoms, such as anxiety and depression, etc. On the contrary, symptoms such as anxiety and depression worsen asthma control. Acupuncture is commonly applied as an effective traditional Chinese medical therapy for asthma. Acupoints GV14, BL13 and BL12 are adopted for the intervention of asthma. GV20 and GV29 are selected to improve emotional symptoms including depression. Nevertheless, standardized therapeutic regimens of acupuncture for asthma and its concomitant emotional symptoms are still lacking. 180 patients with mild to moderate asthma will be recruited in this multicenter randomized controlled trial, randomly assigned to the true acupuncture group, sham acupuncture group and usual care group. The primary outcome is the score of the Asthma Control Test (ACT). Secondary outcomes include the Hospital Anxiety and Depression Scale (HADS), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function, and fractional exhaled nitric oxide (FeNO). The superiority of combined acupuncture therapy in improving asthma control, relieving negative emotions, and enhancing quality of life is to be verified in this study, with high quality evidence for acupuncture treatment of asthma thereby to be provided.
- Conditions
- Asthma Chronic, Asthma (Diagnosis), Asthma
- Being tested
- Acupuncture, Sham Acupuncture, Usual Care
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Patients are seated with routine disinfection of acupoints. Dazhui (GV14) is perpendicularly needled 0.5-1 cun; Feishu (BL13) and Fengmen (BL12) are perpendicularly needled toward the spine for 0.5-0.8 cun; Baihui (GV20) is needled subcutaneously at 15-30° to the scalp for 0.5 cun; Yintang (GV29) is obliquely needled downward for 0.3-0.5 cun after pinching local skin . Even reinforcing-reducing manipulation is adopted. Each treatment lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions. Eye masks are used, with separation of operators and outcome assessors.
Sham AcupunctureProcedure or surgery
Patients are seated with routine disinfection of acupoints. Streitberger non-penetrating placebo needles are applied to the same acupoints as true acupuncture (Dazhui GV14, Feishu BL13, Fengmen BL12, Baihui GV20, Yintang GV29) with identical position, duration and frequency. Each sham session lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions. Eye masks are used, with separation of operators and outcome assessors.
Usual CareOther
Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.
| Study group | Role | What they receive |
|---|---|---|
| True Acupuncture Group | Experimental | Acupuncture Group: On routine standard asthma treatment, participants receive acupuncture. Disposable sterile needles (Wuxi Jiajian Medical Instrument Co., Ltd.) are used: 0.25 mm×25 mm for Baihui (GV20), Yintang (GV29); 0.30 mm×40 mm for Dazhui (GV14), bilateral Fengmen (BL12) and Feishu (BL13).Qualified acupuncturists perform treatment following GB/T 12346-2021. Patients sit with routine skin disinfection. Baihui: 15-30° oblique insertion, 0.5 cun. Yintang: downward oblique puncture 0.3-0.5 cun with skin pinched. Dazhui: perpendicular 0.5-1 cun. Fengmen and Feishu: perpendicular toward spine, 0.5-0.8 cun. Even reinforcing-reducing manipulation is applied. Each session lasts 30 minutes, 3 times weekly for 10 sessions. Eye masks are used; operators are separated from outcome assessors. Receives: Procedure: Acupuncture |
| Sham Acupuncture Group | Sham comparator | Sham Acupuncture Group: On the basis of routine standard asthma treatment, participants receive Streitberger placebo needle intervention. The Streitberger placebo needle (Asiamed GmbH, Germany) is a non-penetrating sham acupuncture device with identical appearance to real needles but a blunt tip. Upon gentle skin contact, the shaft retracts into the handle, secured by an external patch to simulate needle insertion visually. The same acupoints are used as in the acupuncture group: GV14, BL13, BL12, GV20 and GV29.Participants sit with routine skin disinfection. The placebo needle base pad is fixed on acupoints. Vertical pressure on the handle retracts the shaft without skin penetration. Each session lasts 30 minutes, 3 times weekly for 10 consecutive sessions. Needles are removed directly without hemostasis. Eye masks are used during treatment; operators are separated from outcome assessors. Receives: Procedure: Sham Acupuncture |
| Usual Care Group | Active comparator | Participants receive only standard pharmacological treatment for asthma in accordance with clinical guidelines, without any acupuncture or related interventions. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT)
The Asthma Control Test (ACT) is a validated 5-item self-reported questionnaire assessing overall asthma control, with total scores ranging from 5 to 25. Higher scores indicate better asthma control.
Measured: Change from baseline to week 4 (end of treatment)
Secondary outcomes (2)
Hospital Anxiety and Depression Scale (HADS)
A validated self-rating scale containing anxiety (HADS-A) and depression (HADS-D) subscales, each with 7 items. Lower scores indicate less anxiety and depressive symptoms.
Measured: Change from baseline to week 4 (end of treatment)
Asthma-Specific Quality of Life Questionnaire (AQLQ)
A validated self-reported questionnaire evaluating asthma-related quality of life, covering symptoms, activity limitation, emotional function and environmental stimuli. Higher scores represent better quality of life.
Measured: Change from baseline to week 4 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start21 May 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChronicStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Hospital of Traditional Chinese Medicine, Longhua Hospital, Shanghai Yueyang Integrated Medicine Hospital
- Responsible party
- Principal investigator, Lei-Miao Yin, Shanghai Municipal Hospital of Traditional Chinese Medicine
- Investigators
- Lei-Miao Yin, MD, Study director, Shanghai Municipal Hospital of Traditional Chinese MedicinePing Yin, MD, Study chair, Longhua HospitalXin-Yun Huang, MD, Study chair, Yueyang Hospital, Shanghai University of Traditional Chinese medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611955
- Sponsor's protocol ID
- 2026SHL-KY-68-01
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy protection and limited research resources
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupuncture on Patients With Chronic Asthma: a Multicenter, Randomized, Three-arm, Sham-controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT07611955
- Acronym / sponsor ID
- 2026SHL-KY-68-01
- Conditions
- Asthma Chronic, Asthma (Diagnosis), Asthma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Municipal Hospital of Traditional Chinese Medicine, Longhua Hospital, Shanghai Yueyang Integrated Medicine Hospital
- Study start
- 21 May 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 May 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.
Asthma is a common chronic respiratory disease with a low clinical control rate, highlighting the need for novel therapeutic strategies. Recurrent asthma attacks emotional symptoms, such as anxiety and depression, etc. On the contrary, symptoms such as anxiety and depression worsen asthma control. Acupuncture is commonly applied as an effective traditional Chinese medical therapy for asthma. Acupoints GV14, BL13 and BL12 are adopted for the intervention of asthma. GV20 and GV29 are selected to improve emotional symptoms including depression. Nevertheless, standardized therapeutic regimens of acupuncture for asthma and its concomitant emotional symptoms are still lacking. 180 patients with mild to moderate asthma will be recruited in this multicenter randomized controlled trial, randomly assigned to the true acupuncture group, sham acupuncture group and usual care group. The primary outcome is the score of the Asthma Control Test (ACT). Secondary outcomes include the Hospital Anxiety and Depression Scale (HADS), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function, and fractional exhaled nitric oxide (FeNO). The superiority of combined acupuncture therapy in improving asthma control, relieving negative emotions, and enhancing quality of life is to be verified in this study, with high quality evidence for acupuncture treatment of asthma thereby to be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True Acupuncture Group | Experimental | Procedure: AcupunctureAcupuncture Group: On routine standard asthma treatment, participants receive acupuncture. Disposable sterile needles (Wuxi Jiajian Medical Instrument Co., Ltd.) are used: 0.25 mm×25 mm for Baihui (GV20), Yintang (GV29); 0.30 mm×40 mm for Dazhui (GV14), bilateral Fengmen (BL12) and Feishu (BL13).Qualified acupuncturists perform treatment following GB/T 12346-2021. Patients sit with routine skin disinfection. Baihui: 15-30° oblique insertion, 0.5 cun. Yintang: downward oblique puncture 0.3-0.5 cun with skin pinched. Dazhui: perpendicular 0.5-1 cun. Fengmen and Feishu: perpendicular toward spine, 0.5-0.8 cun. Even reinforcing-reducing manipulation is applied. Each session lasts 30 minutes, 3 times weekly for 10 sessions. Eye masks are used; operators are separated from outcome assessors. |
| Sham Acupuncture Group | Sham comparator | Procedure: Sham AcupunctureSham Acupuncture Group: On the basis of routine standard asthma treatment, participants receive Streitberger placebo needle intervention. The Streitberger placebo needle (Asiamed GmbH, Germany) is a non-penetrating sham acupuncture device with identical appearance to real needles but a blunt tip. Upon gentle skin contact, the shaft retracts into the handle, secured by an external patch to simulate needle insertion visually. The same acupoints are used as in the acupuncture group: GV14, BL13, BL12, GV20 and GV29.Participants sit with routine skin disinfection. The placebo needle base pad is fixed on acupoints. Vertical pressure on the handle retracts the shaft without skin penetration. Each session lasts 30 minutes, 3 times weekly for 10 consecutive sessions. Needles are removed directly without hemostasis. Eye masks are used during treatment; operators are separated from outcome assessors. |
| Usual Care Group | Active comparator | Other: Usual CareParticipants receive only standard pharmacological treatment for asthma in accordance with clinical guidelines, without any acupuncture or related interventions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria for asthma, and be in the chronic persistent phase with mild to moderate disease severity, referring to the grading criteria of the Guidelines for the Prevention and Treatment of Asthma (2024 Edition).
- Aged 18 to 70 years, regardless of gender.
- Asthma Control Test (ACT) score≤19 points (poorly controlled or very poorly controlled asthma).
- Maintain a stable asthma treatment regimen for at least 4 weeks before enrollment.
- Clear thinking and consciousness, coherent responses, able to understand the items of various scales and complete the assessment.
Key exclusion criteria (8 listed)
- Complicated with severe mental illnesses (such as uncontrolled schizophrenia, acute phase of bipolar disorder, etc.) or moderate to severe cognitive impairment (such as dementia), resulting in inability to understand the research process or cooperate with efficacy evaluation.
- A history of substance/alcohol dependence within the past 12 months.
- Complicated with other physical diseases that may cause depressive symptoms (such as hypothyroidism, chronic pain syndrome, malignant tumors, rheumatoid arthritis, etc.).
- Received antidepressant drug treatment within the past 6 months.
- Suffering from other respiratory diseases, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, etc.
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 |
|---|---|---|
| AcupuncturePatients are seated with routine disinfection of acupoints. Dazhui (GV14) is perpendicularly needled 0.5-1 cun; Feishu (BL13) and Fengmen (BL12) are perpendicularly needled toward the spine for 0.5-0.8 cun; Baihui (GV20) is needled subcutaneously at 15-30° to the scalp for 0.5 cun; Yintang (GV29) is obliquely needled downward for 0.3-0.5 cun after pinching local skin . Even reinforcing-reducing manipulation is adopted. Each treatment lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions. Eye masks are used, with separation of operators and outcome assessors. | Procedure or surgery | True Acupuncture Group |
| Sham AcupuncturePatients are seated with routine disinfection of acupoints. Streitberger non-penetrating placebo needles are applied to the same acupoints as true acupuncture (Dazhui GV14, Feishu BL13, Fengmen BL12, Baihui GV20, Yintang GV29) with identical position, duration and frequency. Each sham session lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions. Eye masks are used, with separation of operators and outcome assessors. | Procedure or surgery | Sham Acupuncture Group |
| Usual CarePatients receive routine asthma pharmacological treatment without additional acupuncture intervention. | Other | Usual Care Group |
Primary outcome
Asthma Control Test (ACT)
Time frame: Change from baseline to week 4 (end of treatment)
The Asthma Control Test (ACT) is a validated 5-item self-reported questionnaire assessing overall asthma control, with total scores ranging from 5 to 25. Higher scores indicate better asthma control.
2 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline to week 4 (end of treatment)
Asthma-Specific Quality of Life Questionnaire (AQLQ)
Time frame: Change from baseline to week 4 (end of treatment)
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 1 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy protection and limited research resources
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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.
Lei-Miao Yin, MD study director
Shanghai Municipal Hospital of Traditional Chinese Medicine
Ping Yin, MD study chair
Longhua Hospital
Xin-Yun Huang, MD study chair
Yueyang Hospital, Shanghai University of Traditional Chinese medicine
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Asthma Chronic and Asthma (Diagnosis), run by Shanghai 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 6 inclusion and 8 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 1 Jun 2026. 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. 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.
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 Lei-Miao Yin, MD (+86 21 56639828, collegeylm@shutcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) (time frame: Change from baseline to week 4 (end of treatment)). 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 1 Jun 2026.