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NCT Number: NCT07611955

A Study of Acupuncture for Treating Asthma

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.

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Key information

Conditions

Asthma Chronic Asthma Asthma (Diagnosis) Bronchial Diseases Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Usual Care

Other

Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Change from baseline to week 4 (end of treatment)

    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.

  2. Asthma-Specific Quality of Life Questionnaire (AQLQ)

    Time frame: Change from baseline to week 4 (end of treatment)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei-Miao Yin, MD

CONTACT

[email protected]

+86 21 56639828

Xin Luan, MD

CONTACT

[email protected]

+86 17701614380

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Longhua Hospital
  • Shanghai Municipal Hospital of Traditional Chinese Medicine
  • Shanghai Yueyang Integrated Medicine Hospital

Registry information

Official study title

The Effects of Acupuncture on Patients With Chronic Asthma: a Multicenter, Randomized, Three-arm, Sham-controlled Superiority Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 28, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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