NCT01931696

Brief Summary

The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

12 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

August 26, 2013

Last Update Submit

February 25, 2026

Conditions

Asthma

Keywords

EfficacyAcupunctureAsthma

Outcome Measures

Primary Outcomes (1)

  • Total score Change from Baseline of Asthma Control Test

    Measured during the 6 week treatment period

Secondary Outcomes (7)

  • Percentage of symptom-free days

    Measured during the 6 week treatment period

  • Usage of salbutamol and prednisone

    Measured during the 6 week treatment period

  • Lung function(FEV1, PVC, FEV1/FVC%, FEV1/predicted%)，morning/evening PEF

    Measured during the 6 week treatment period

  • Asthma symptom scores

    Measured during the 6 week treatment period

  • Asthma quality of Life Questionnaire(AQLQ)

    Measured during the 6 week treatment period

  • +2 more secondary outcomes

Study Arms (2)

Verum acupuncture

EXPERIMENTAL

Verum acupuncture treatment once every two days + Albuterol sulfate HFA (Ventolin®™ 100 mcg Inhalation Aerosol) as needed + Prednisone Acetate Tablets(H31020675, 5 mg oral tablet) for exacerbation

Device: Verum acupuncture

Sham acupuncture

SHAM COMPARATOR

Sham acupuncture treatment once every two days + Albuterol sulfate HFA (Ventolin®™ 100 mcg Inhalation Aerosol) as needed + Prednisone Acetate Tablets(H31020675, 5 mg oral tablet) for exacerbation

Device: Sham acupuncture

Interventions

Verum acupunctureDEVICE

100 patients receive verum acupuncture treatment once every other day,choosing Dazhui(GV14), Fengmen(BL12), Feishu(BL13), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive verum acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.

Verum acupuncture
Sham acupunctureDEVICE

100 patients receive sham acupuncture treatment once every other day, choosing Jinsuo(DU08), Ganshu(BL18), Danshu(BL19), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive sham acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.

Sham acupuncture

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with mild-to-moderate persistent asthma
  • Forced expiratory volume in one second (FEV1) reversibility of greater than or equal to 12% following bronchodilator administration (2 puffs)
  • Patients who have given written informed consent

You may not qualify if:

  • Participation in another clinical trial 1 month prior to study entry
  • Use of systemic corticosteroids 2 weeks prior to study entry
  • Patients with general infection, lower respiratory infection, pulmonary tuberculosis and fungal infection 1 month prior to study entry
  • Hospitalization due to acute exacerbation 3 months prior to study entry
  • Patients cannot stop using forbidden drugs which include inhaled corticosteroid, theophylline, long-term β2 agonist, sodium cromoglicate, leukotrienes antagonist and anticholinergic drug
  • Patients who are allergic to albuterol and corticosteroid
  • Patients with severe primary diseases such as cancer, cardiovascular system, liver, kidney and hematopoietic system diseases
  • Wheeze caused by pulmonary tuberculosis, bronchiectasia and cardiac insufficiency
  • Patients with hyperthyroidism
  • Patients with mental illness, acrasia
  • Female patients in pregnancy, lactation period and planning to get pregnant during the trial
  • Any significant disorder that in the investigator's opinion, might put the patients at risk or influence the study outcomes
  • Acupuncture contraindications: serious allergic or infectious dermatitis and hemorrhagic diseases such as thrombocytopenic purpura and hemophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University Hospital of Gansu Traditional Chinese Medicine

Lanzhou, Gansu, China

Location

Kaifeng Traditional Chinese Medicine hospital

Kaifeng, Henan, 475000, China

Location

No.3 hospital of Henan college of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Zhengzhou Traditional Chinese Medicine hospital

Zhengzhou, Henan, 450000, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai research institute of acupuncture and meridian，Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Dachang hospital

Shanghai, Shanghai Municipality, 201900, China

Location

Longhua Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai TCM Integrated hospital

Shanghai, Shanghai Municipality, China

Location

Shuguang Hospital

Shanghai, Shanghai Municipality, China

Location

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, China

Location

Related Publications (2)

  • Long J, Cheng M, Wu QL, Zhang YY, Wang Y, Chen YJ, Yin LM, Yang YQ, Xu YD. Acupuncture Attenuates Allergic Airway Inflammation via CC10-Mediated Modulation of Lung Dendritic Cells. Front Biosci (Landmark Ed). 2026 Mar 9;31(3):48140. doi: 10.31083/FBL48140.

    PMID: 41914302DERIVED

  • Yin LM, Wang Y, Fan L, Xu YD, Wang WQ, Liu YY, Feng JT, Hu CP, Wang PY, Zhang TF, Shao SJ, Yang YQ. Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial. Trials. 2015 Sep 23;16:424. doi: 10.1186/s13063-015-0947-z.

    PMID: 26399399DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yong-Qing Yang, Ph.D

    Shanghai University of TCM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

July 1, 2015

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

CN(12)