Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
2. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
72
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Qinmei Yang
- Telefonnummer: 15981845716
- E-post: yangqinmei840105@126.com
Studiesteder
-
-
Henan
-
Zhengzhou, Henan, Kina, 450000
- Rekruttering
- The First Affiliated Hospital of Henan University of Chinese Medicine
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Ta kontakt med:
- Qinmei Yang
- Telefonnummer: 15981845716
- E-post: yangqinmei840105@126.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak Expiratory Flow(PEF)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Forced expiratory volume in first second/pred（FEV1%pred）
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. april 2025
Primær fullføring (Antatt)
15. september 2026
Studiet fullført (Antatt)
1. januar 2027
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
2. juni 2026
Først lagt ut (Faktiske)
8. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
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