Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture, Standard Western medicine treatment.
- Who it may be relevant to
- Registry conditions: Bronchial Asthma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma Based on Biological Holography Theory
Overview
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.
Detailed description
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.
Interventions
- Other 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. - Drug 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 ).
Primary outcome measures
- Peak Expiratory Flow(PEF) [Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
- Asthma Control Test [Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
Secondary outcome measures (7)
- Forced expiratory volume in first second/pred（FEV1%pred） [Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
- Clinical Symptom and Sign Score [Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
- Mini Asthma Quality of Life Questionnaire（Mini-AQLQ) [Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
- modified Medical Research Council (mMRC) [Time frame: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
- Interleukin 4 (IL-4) [Time frame: After treatment on Day 5]
- Eotaxin [Time frame: After treatment on Day 5]
- IgE [Time frame: After treatment on Day 5]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou
Identifiers
NCT: NCT07632352 · TCM for BA