A Study of Acupuncture for Treating Asthma
28 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
180
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Lei-Miao Yin, MD
- Número de teléfono: +86 21 56639828
- Correo electrónico: collegeylm@shutcm.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Xin Luan, MD
- Número de teléfono: +86 17701614380
- Correo electrónico: lx931163088@163.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
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 activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Asthma Control Test (ACT)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Lei-Miao Yin, MD, Shanghai Municipal Hospital of Traditional Chinese Medicine
- Silla de estudio: Ping Yin, MD, Longhua Hospital
- Silla de estudio: Xin-Yun Huang, MD, Yueyang Hospital, Shanghai University of Traditional Chinese medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
21 de mayo de 2026
Finalización primaria (Estimado)
1 de marzo de 2028
Finalización del estudio (Estimado)
1 de septiembre de 2028
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2026
Publicado por primera vez (Actual)
28 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del sistema inmunológico
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Condiciones Patológicas, Signos y Síntomas
- Asma
- Enfermedad
- Terapéutica
- Terapias complementarias
- Terapia de acupuntura
Otros números de identificación del estudio
- 2026SHL-KY-68-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared due to participant privacy protection and limited research resources
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .