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A Study of Acupuncture for Treating Asthma

28 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

180

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Procedimento: 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.
Comparador Falso: 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.
Procedimento: 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.
Comparador Ativo: Usual Care Group
Participants receive only standard pharmacological treatment for asthma in accordance with clinical guidelines, without any acupuncture or related interventions.
Outro: Usual Care
Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Asthma Control Test (ACT)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hospital Anxiety and Depression Scale (HADS)
Prazo: 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)
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai University of Traditional Chinese Medicine

Colaboradores

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

Investigadores

  • Diretor de estudo: Lei-Miao Yin, MD, Shanghai Municipal Hospital of Traditional Chinese Medicine
  • Cadeira de estudo: Ping Yin, MD, Longhua Hospital
  • Cadeira de estudo: Xin-Yun Huang, MD, Yueyang Hospital, Shanghai University of Traditional Chinese medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

21 de maio de 2026

Conclusão Primária (Estimado)

1 de março de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

28 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026SHL-KY-68-01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared due to participant privacy protection and limited research resources

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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