A Study of Acupuncture for Treating Asthma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai University of Traditional Chinese Medicine
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Procedure/SurgeryPatients 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/SurgeryPatients 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 interventionPatients receive routine asthma pharmacological treatment without additional acupuncture intervention.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: True Acupuncture GroupExperimental treatment 1 intervention
Group B: Sham Acupuncture GroupSham comparator 1 intervention
Group C: Usual Care GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Change from baseline to week 4 (end of treatment)Secondary outcomes
1
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.
Time frame
Change from baseline to week 4 (end of treatment)2
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.
Time frame
Change from baseline to week 4 (end of treatment)Locations
Sponsors and contacts
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Shanghai University of Traditional Chinese Medicine
Lead sponsor
Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor institution
Shanghai Municipal Hospital of Traditional Chinese Medicine
Collaborator
Longhua Hospital
Collaborator
Shanghai Yueyang Integrated Medicine Hospital
Collaborator
Source ClinicalTrials.gov
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