Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchial Asthma
• Intervention / Treatment: Other: Acupuncture; Drug: Standard Western medicine treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qinmei Yang; Phone Number: 15981845716; Email: yangqinmei840105@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Qinmei Yang; Phone Number: 15981845716; Email: yangqinmei840105@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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 ).
Active Comparator: control group; The control group received standard Western medicine treatment	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 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Expiratory Flow(PEF)	PEF will be used to assess pulmonary function	After treatment on Day 5 and follow-up at 1, 2 and 3 months
Asthma Control Test	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.	After treatment on Day 5 and follow-up at 1, 2 and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced expiratory volume in first second/pred（FEV1%pred）	FEV1%pred will be used to assess pulmonary function	After treatment on Day 5 and follow-up at 1, 2 and 3 months
Clinical Symptom and Sign Score	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.	After treatment on Day 5 and follow-up at 1, 2 and 3 months
Mini Asthma Quality of Life Questionnaire（Mini-AQLQ)	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.	After treatment on Day 5 and follow-up at 1, 2 and 3 months
modified Medical Research Council (mMRC)	Scores range from 0 to 4 based on the severity of dyspnea, with higher scores indicating more severe symptoms.	After treatment on Day 5 and follow-up at 1, 2 and 3 months
Interleukin 4 (IL-4)	Detect the level of IL-4 in peripheral blood	After treatment on Day 5
Eotaxin	Detect the level of Eotaxin in peripheral blood	After treatment on Day 5
IgE	Detect the level of IgE in peripheral blood	After treatment on Day 5

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; acute exacerbation; bronchial asthma; Biological holography theory
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: TCM for BA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No