A Study of Acupuncture for Treating Asthma
21 maggio 2026 aggiornato da: Lei-Miao Yin, Shanghai University of Traditional Chinese Medicine
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
180
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Lei-Miao Yin, MD
- Numero di telefono: +86 21 56639828
- Email: collegeylm@shutcm.edu.cn
Backup dei contatti dello studio
- Nome: Xin Luan, MD
- Numero di telefono: +86 17701614380
- Email: lx931163088@163.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Comparatore fittizio: 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.
|
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.
|
|
Comparatore attivo: Usual Care Group
Participants receive only standard pharmacological treatment for asthma in accordance with clinical guidelines, without any acupuncture or related interventions.
|
Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Asthma Control Test (ACT)
Lasso di tempo: 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.
|
Change from baseline to week 4 (end of treatment)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: 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.
|
Change from baseline to week 4 (end of treatment)
|
|
Asthma-Specific Quality of Life Questionnaire (AQLQ)
Lasso di tempo: 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.
|
Change from baseline to week 4 (end of treatment)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Direttore dello studio: Lei-Miao Yin, MD, Shanghai Municipal Hospital of Traditional Chinese Medicine
- Cattedra di studio: Ping Yin, MD, Longhua Hospital
- Cattedra di studio: Xin-Yun Huang, MD, Yueyang Hospital, Shanghai University of Traditional Chinese medicine
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
21 maggio 2026
Completamento primario (Stimato)
1 marzo 2028
Completamento dello studio (Stimato)
1 settembre 2028
Date di iscrizione allo studio
Primo inviato
21 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
21 maggio 2026
Primo Inserito (Effettivo)
28 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema immunitario
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità, immediata
- Ipersensibilità
- Condizioni patologiche, segni e sintomi
- Asma
- Patologia
- Terapie
- Terapie complementari
- Terapia di agopuntura
Altri numeri di identificazione dello studio
- 2026SHL-KY-68-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be shared due to participant privacy protection and limited research resources
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .