- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07632352
Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
2026년 6월 2일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
72
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Qinmei Yang
- 전화번호: 15981845716
- 이메일: yangqinmei840105@126.com
연구 장소
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Henan
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Zhengzhou, Henan, 중국, 450000
- 모병
- the First Affiliated Hospital of Henan University of Chinese Medicine
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연락하다:
- Qinmei Yang
- 전화번호: 15981845716
- 이메일: yangqinmei840105@126.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Expiratory Flow(PEF)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Forced expiratory volume in first second/pred(FEV1%pred)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 4월 15일
기본 완료 (추정된)
2026년 9월 15일
연구 완료 (추정된)
2027년 1월 1일
연구 등록 날짜
최초 제출
2026년 6월 2일
QC 기준을 충족하는 최초 제출
2026년 6월 2일
처음 게시됨 (실제)
2026년 6월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 2일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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