Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
2 de junho de 2026 atualizado por: Henan University of Traditional Chinese Medicine
Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma Based on Biological Holography Theory
Based on the bioholographic theory, this study preliminarily explores the clinical efficacy of hand acupuncture in treating acute exacerbation of bronchial asthma and evaluates its immediate anti-asthmatic effect, so as to provide a new therapeutic strategy for the clinical management of bronchial asthma.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
This study adopted a randomized controlled trial design, with patients in the acute exacerbation phase of bronchial asthma as the research subjects.
A total of 72 patients who met the inclusion criteria were randomly divided into the acupuncture group and the control group in a 1:1 ratio.
The control group received standard Western medicine treatment, while the acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment.
The acupoints selected were Kechuan point, New Kechuan point, and Yuji point.
The treatment was administered once a day for 20 minutes each time, for 5 consecutive days, with a 3-month follow-up.
The therapeutic efficacy of manual acupuncture in treating acute exacerbation of bronchial asthma was evaluated with indicators including symptom and sign scores, pulmonary function, ACT , mMRC , Mini-AQLQ scale, serum interleukin-4 (IL-4), serum eotaxin and specific immunoglobulin E (SIgE).
In addition, the underlying therapeutic mechanism was preliminarily explored to formulate a technical protocol for rapid anti-asthma acupuncture, laying a foundation for long-term and objective efficacy evaluation of this therapy.
Tipo de estudo
Intervencional
Inscrição (Estimado)
72
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
- Nome: Qinmei Yang
- Número de telefone: 15981845716
- E-mail: yangqinmei840105@126.com
Locais de estudo
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Henan
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Zhengzhou, Henan, China, 450000
- Recrutamento
- The First Affiliated Hospital of Henan University of Chinese Medicine
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Contato:
- Qinmei Yang
- Número de telefone: 15981845716
- E-mail: yangqinmei840105@126.com
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-
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:
- Patients meeting the Western medicine diagnostic criteria for acute exacerbation of bronchial asthma
- Aged ≥ 18 years old
- Voluntarily receive treatment and sign the informed consent form
Exclusion Criteria:
- Those who fail to meet the inclusion criteria
- Patients suffering from other severe systemic diseases such as diseases of the circulatory system, hematological system and nervous system
- Pregnant or lactating women
- Subjects enrolled but not treated per the study protocol
- Patients who have participated in other clinical trials of medicinal products within 3 months
- Other circumstances deemed ineligible for enrollment by researchers
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: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: acupuncture group
The acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment.
The acupoints selected were Kechuan point, New Kechuan point, and Yuji point.
The treatment was administered once a day for 20 minutes each time, for 5 consecutive days
|
The acupoints selected were Kechuan point, New Kechuan point, and Yuji point.
The treatment was administered once a day for 20 minutes each time, for 5 consecutive days.
Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).
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Comparador Ativo: control group
The control group received standard Western medicine treatment
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Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peak Expiratory Flow(PEF)
Prazo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
PEF will be used to assess pulmonary function
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After treatment on Day 5 and follow-up at 1, 2 and 3 months
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Asthma Control Test
Prazo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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The ACT score consists of 5 questions, each scored from 1 to 5 points, with a total score ranging from 5 to 25 points; lower scores indicate more severe symptoms.
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After treatment on Day 5 and follow-up at 1, 2 and 3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Forced expiratory volume in first second/pred（FEV1%pred）
Prazo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
FEV1%pred will be used to assess pulmonary function
|
After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
|
Clinical Symptom and Sign Score
Prazo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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It includes six symptoms: cough, expectoration, chest tightness, wheezing, shortness of breath and wheeze.
Scores of 0, 3, 6 and 9 are assigned according to the severity of symptoms, with higher scores corresponding to more severe symptoms.
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After treatment on Day 5 and follow-up at 1, 2 and 3 months
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Mini Asthma Quality of Life Questionnaire（Mini-AQLQ)
Prazo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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It consists of 15 questions, each scored on a scale from 1 to 7 based on the severity of symptoms and their degree of impact.
A score of 1 indicates no symptoms or no adverse impacts, while a score of 7 stands for severe symptoms or substantial impairment.
Lower total scores correspond to a higher quality of life.
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After treatment on Day 5 and follow-up at 1, 2 and 3 months
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modified Medical Research Council (mMRC)
Prazo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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Scores range from 0 to 4 based on the severity of dyspnea, with higher scores indicating more severe symptoms.
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After treatment on Day 5 and follow-up at 1, 2 and 3 months
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Interleukin 4 (IL-4)
Prazo: After treatment on Day 5
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Detect the level of IL-4 in peripheral blood
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After treatment on Day 5
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Eotaxin
Prazo: After treatment on Day 5
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Detect the level of Eotaxin in peripheral blood
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After treatment on Day 5
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IgE
Prazo: After treatment on Day 5
|
Detect the level of IgE in peripheral blood
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After treatment on Day 5
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 (Real)
15 de abril de 2025
Conclusão Primária (Estimado)
15 de setembro de 2026
Conclusão do estudo (Estimado)
1 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TCM for BA
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
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