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Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma

2 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Werving
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Patients meeting the Western medicine diagnostic criteria for acute exacerbation of bronchial asthma
  2. Aged ≥ 18 years old
  3. Voluntarily receive treatment and sign the informed consent form

Exclusion Criteria:

  1. Those who fail to meet the inclusion criteria
  2. Patients suffering from other severe systemic diseases such as diseases of the circulatory system, hematological system and nervous system
  3. Pregnant or lactating women
  4. Subjects enrolled but not treated per the study protocol
  5. Patients who have participated in other clinical trials of medicinal products within 3 months
  6. Other circumstances deemed ineligible for enrollment by researchers

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Ander: Acupuncture
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.
Geneesmiddel: Standard Western medicine treatment
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 ).
Actieve vergelijker: control group
The control group received standard Western medicine treatment
Geneesmiddel: Standard Western medicine treatment
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 ).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Peak Expiratory Flow(PEF)
Tijdsspanne: After treatment on Day 5 and follow-up at 1, 2 and 3 months
PEF will be used to assess pulmonary function
After treatment on Day 5 and follow-up at 1, 2 and 3 months
Asthma Control Test
Tijdsspanne: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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.
After treatment on Day 5 and follow-up at 1, 2 and 3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Forced expiratory volume in first second/pred（FEV1%pred）
Tijdsspanne: 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
Tijdsspanne: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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.
After treatment on Day 5 and follow-up at 1, 2 and 3 months
Mini Asthma Quality of Life Questionnaire（Mini-AQLQ)
Tijdsspanne: After treatment on Day 5 and follow-up at 1, 2 and 3 months
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.
After treatment on Day 5 and follow-up at 1, 2 and 3 months
modified Medical Research Council (mMRC)
Tijdsspanne: After treatment on Day 5 and follow-up at 1, 2 and 3 months
Scores range from 0 to 4 based on the severity of dyspnea, with higher scores indicating more severe symptoms.
After treatment on Day 5 and follow-up at 1, 2 and 3 months
Interleukin 4 (IL-4)
Tijdsspanne: After treatment on Day 5
Detect the level of IL-4 in peripheral blood
After treatment on Day 5
Eotaxin
Tijdsspanne: After treatment on Day 5
Detect the level of Eotaxin in peripheral blood
After treatment on Day 5
IgE
Tijdsspanne: After treatment on Day 5
Detect the level of IgE in peripheral blood
After treatment on Day 5

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Henan University of Traditional Chinese Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 april 2025

Primaire voltooiing (Geschat)

15 september 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TCM for BA

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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