Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
2 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
72
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: Qinmei Yang
- Numero di telefono: 15981845716
- Email: yangqinmei840105@126.com
Luoghi di studio
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Henan
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Zhengzhou, Henan, Cina, 450000
- Reclutamento
- the First Affiliated Hospital of Henan University of Chinese Medicine
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Contatto:
- Qinmei Yang
- Numero di telefono: 15981845716
- Email: yangqinmei840105@126.com
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-
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:
- 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
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: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Peak Expiratory Flow(PEF)
Lasso di tempo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Forced expiratory volume in first second/pred（FEV1%pred）
Lasso di tempo: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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FEV1%pred 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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Clinical Symptom and Sign Score
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: After treatment on Day 5
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Detect the level of IgE in peripheral blood
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After treatment on Day 5
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
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 (Effettivo)
15 aprile 2025
Completamento primario (Stimato)
15 settembre 2026
Completamento dello studio (Stimato)
1 gennaio 2027
Date di iscrizione allo studio
Primo inviato
2 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
2 giugno 2026
Primo Inserito (Effettivo)
8 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TCM for BA
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 .