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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Rekruttering
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: 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.
Medicin: 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 ).
Aktiv komparator: control group
The control group received standard Western medicine treatment
Medicin: 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 ).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak Expiratory Flow(PEF)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forced expiratory volume in first second/pred（FEV1%pred）
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: After treatment on Day 5
Detect the level of IL-4 in peripheral blood
After treatment on Day 5
Eotaxin
Tidsramme: After treatment on Day 5
Detect the level of Eotaxin in peripheral blood
After treatment on Day 5
IgE
Tidsramme: After treatment on Day 5
Detect the level of IgE in peripheral blood
After treatment on Day 5

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Henan University of Traditional Chinese Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2025

Primær færdiggørelse (Anslået)

15. september 2026

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

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