NCT07632352

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Apr 2025Jan 2027

Study Start

First participant enrolled

April 15, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Bronchial Asthma

Keywords

bronchial asthmaacute exacerbationBiological holography theoryAcupuncture

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Forced expiratory volume in first second/pred（FEV1%pred）

    After treatment on Day 5 and follow-up at 1, 2 and 3 months

  • Clinical Symptom and Sign Score

    After treatment on Day 5 and follow-up at 1, 2 and 3 months

  • Mini Asthma Quality of Life Questionnaire（Mini-AQLQ)

    After treatment on Day 5 and follow-up at 1, 2 and 3 months

  • modified Medical Research Council (mMRC)

    After treatment on Day 5 and follow-up at 1, 2 and 3 months

  • Interleukin 4 (IL-4)

    After treatment on Day 5

  • +2 more secondary outcomes

Study Arms (2)

acupuncture group

EXPERIMENTAL

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: AcupunctureDrug: Standard Western medicine treatment

control group

ACTIVE COMPARATOR

The control group received standard Western medicine treatment

Drug: Standard Western medicine treatment

Interventions

AcupunctureOTHER

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.

acupuncture group
Standard Western medicine treatmentDRUG

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 ).

acupuncture groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Qinmei Yang

CONTACT

15981845716yangqinmei840105@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

April 15, 2025

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations

CN(1)