A Study of Acupuncture for Treating Asthma

NCT07611955 | Not Yet Recruiting

• 1 other identifier: 2026SHL-KY-68-01
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to week 4 (end of treatment)

Secondary Outcomes (2)

• Hospital Anxiety and Depression Scale (HADS)

  Change from baseline to week 4 (end of treatment)

• Asthma-Specific Quality of Life Questionnaire (AQLQ)

  Change from baseline to week 4 (end of treatment)

Study Arms (3)

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.

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.

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.

Other: Usual Care

Interventions

Acupuncture PROCEDURE

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.

True Acupuncture Group

Sham Acupuncture PROCEDURE

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.

Sham Acupuncture Group

Usual Care OTHER

Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Shanghai Municipal Hospital of Traditional Chinese Medicine: collaborator
• Longhua Hospital: collaborator
• Shanghai Yueyang Integrated Medicine Hospital: collaborator

MeSH Terms

Conditions

Asthma; Disease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Lei-Miao Yin, MD

  Shanghai Municipal Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

• Ping Yin, MD

  Longhua Hospital

  STUDY CHAIR

• Xin-Yun Huang, MD

  Yueyang Hospital, Shanghai University of Traditional Chinese medicine

  STUDY CHAIR

Central Study Contacts

Lei-Miao Yin, MD

CONTACT

+86 21 56639828; collegeylm@shutcm.edu.cn

Xin Luan, MD

CONTACT

+86 17701614380; lx931163088@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking is applied to participants and outcome assessors. Participants in the true acupuncture and sham acupuncture groups are blinded to group allocation, while participants in the usual-care group are unblinded. Outcome assessors remain blinded throughout the trial. Acupuncturists and clinical care providers are unblinded due to the nature of acupuncture intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share