A Study of Acupuncture for Treating Asthma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma; Asthma Chronic; Asthma (Diagnosis)
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Sham Acupuncture; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei-Miao Yin, MD; Phone Number: +86 21 56639828; Email: collegeylm@shutcm.edu.cn
• Study Contact Backup: Name: Xin Luan, MD; Phone Number: +86 17701614380; Email: lx931163088@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: True Acupuncture Group; 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; 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 Comparator: Sham Acupuncture Group; 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; 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.
Active Comparator: Usual Care Group; Participants receive only standard pharmacological treatment for asthma in accordance with clinical guidelines, without any acupuncture or related interventions.	Other: Usual Care; Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from baseline to week 4 (end of treatment)

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Shanghai Yueyang Integrated Medicine Hospital; Longhua Hospital; Shanghai Municipal Hospital of Traditional Chinese Medicine
• Investigators: Study Director: Lei-Miao Yin, MD, Shanghai Municipal Hospital of Traditional Chinese Medicine; Study Chair: Ping Yin, MD, Longhua Hospital; Study Chair: Xin-Yun Huang, MD, Yueyang Hospital, Shanghai University of Traditional Chinese medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 21, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Asthma; Disease; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: 2026SHL-KY-68-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to participant privacy protection and limited research resources

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No