Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
2026年6月2日 更新者: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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Qinmei Yang
- 电话号码:15981845716
- 邮箱:yangqinmei840105@126.com
学习地点
-
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Henan
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Zhengzhou、Henan、中国、450000
- 招聘中
- The First Affiliated Hospital of Henan University of Chinese Medicine
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接触:
- Qinmei Yang
- 电话号码:15981845716
- 邮箱:yangqinmei840105@126.com
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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有源比较器: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Peak Expiratory Flow(PEF)
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Forced expiratory volume in first second/pred(FEV1%pred)
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年4月15日
初级完成 (估计的)
2026年9月15日
研究完成 (估计的)
2027年1月1日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月2日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.