Bronchial Asthma
Conditions
Keywords
bronchial asthma, acute exacerbation, Biological holography theory, Acupuncture
Brief summary
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
OTHERAcupuncture
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 ).
Sponsors
Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Expiratory Flow(PEF) | After treatment on Day 5 and follow-up at 1, 2 and 3 months | PEF will be used to assess pulmonary function |
| Asthma Control Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume in first second/pred（FEV1%pred） | After treatment on Day 5 and follow-up at 1, 2 and 3 months | FEV1%pred will be used to assess pulmonary function |
| Clinical Symptom and Sign Score | 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. |
| Mini Asthma Quality of Life Questionnaire（Mini-AQLQ) | 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. |
| modified Medical Research Council (mMRC) | 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. |
| Interleukin 4 (IL-4) | After treatment on Day 5 | Detect the level of IL-4 in peripheral blood |
| Eotaxin | After treatment on Day 5 | Detect the level of Eotaxin in peripheral blood |
| IgE | After treatment on Day 5 | Detect the level of IgE in peripheral blood |
Countries
China
Contacts
CONTACTQinmei Yang
Outcome results
None listed