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AsthmaNCT01931696

Clinical Assessment of Acupuncture for the Treatment of Chronic Asthma

A study testing Verum acupuncture in people with Asthma, run by Shanghai University of Traditional Chinese Medicine at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 14 to 65 years
Conditions the study is for
Asthma
What is being tested?
Verum acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
12 sitesChina
Study dates
Aug 2013to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Kaifeng Traditional Chinese Medicine hospital

    Kaifeng, Henan, 475000

  • University Hospital of Gansu Traditional Chinese Medicine

    Lanzhou, Gansu

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200030

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

    Shanghai, Shanghai Municipality, 200030

  • Shanghai Dachang hospital

    Shanghai, Shanghai Municipality, 201900

  • Longhua Hospital

    Shanghai, Shanghai Municipality

  • Shanghai TCM Integrated hospital

    Shanghai, Shanghai Municipality

  • Shuguang Hospital

    Shanghai, Shanghai Municipality

  • Wenzhou Hospital of Traditional Chinese Medicine

    Wenzhou, Zhejiang

  • No.3 hospital of Henan college of Traditional Chinese Medicine

    Zhengzhou, Henan, 450000

  • Zhengzhou Traditional Chinese Medicine hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial

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

Read the detailed description

Asthma is a common chronic disease worldwide with an estimated 300 million affected individuals. In analyses of economic burden of asthma, apart from direct medical costs including hospital admissions and cost of medications, indirect, non-medical costs such as time lost from work account for a considerable part. For all but the most severe patients, the ultimate goal is to prevent symptoms, minimize morbidity from acute episodes, and prevent functional and psychological morbidity to provide a near healthy lifestyle. Although the symptoms can be controlled by drug treatment in most patients, effective low-risk, non-drug approaches such as acupuncture could constitute a significant advance in asthma management. The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.

There is a 1-week screening period(-1 week) during which participants will be monitored while they use an albuterol inhaler as needed. Study visits will occur at weeks 0(Baseline), weeks 3, weeks 6. Participants will undergo a physical examination, lung function, blood and urine collection. At the Weeks 0 study visit, participants will be randomly assigned to one of the following two groups for 6 weeks of treatment:

  • Group 1 will receive verum acupuncture treatment once every two days plus albuterol as needed, prednisone for exacerbation
  • Group 2 will receive sham acupuncture treatment once every two days plus albuterol as needed, prednisone for exacerbation

Study visits will occur at Weeks 0, 3, 6. A physical examination, blood collection, and lung function will occur at selected visits. Questionnaires to assess asthma control and quality of life will also be completed. Throughout the study, participants will record asthma symptoms and medication usage in a daily diary.

Conditions
Asthma
Being tested
Verum acupuncture, Sham acupuncture
Keywords
Efficacy, Acupuncture, Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT01931696
Study groupRoleWhat they receive
Verum acupunctureExperimentalVerum 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
Receives: Device: Verum acupuncture
Sham acupunctureSham comparatorSham 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
Receives: Device: Sham acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total score Change from Baseline of Asthma Control Test

    Measured: Measured during the 6 week treatment period

Secondary outcomes (7)

  1. Percentage of symptom-free days

    Measured: Measured during the 6 week treatment period

  2. Usage of salbutamol and prednisone

    Measured: Measured during the 6 week treatment period

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

    Measured: Measured during the 6 week treatment period

  4. Asthma symptom scores

    Measured: Measured during the 6 week treatment period

  5. Asthma quality of Life Questionnaire(AQLQ)

    Measured: Measured during the 6 week treatment period

  6. Total number of exacerbations that require systemic corticosteroid therapy

    Measured: Measured during the 6 week treatment period

  7. Eosinophil (EOS) count in peripheral blood, T cell classification, serum cytokine levels

    Measured: Measured during the 6 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionFeb 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931696
Sponsor's protocol ID
ZYSNXD-CC-ZDYJ039
Status last verified
Feb 2026
First submitted
26 Aug 2013
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41914302

  • 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.

    PubMed 26399399

Questions about this trial

What is this clinical trial studying?

A study testing Verum acupuncture in people with Asthma, run by Shanghai University of Traditional Chinese Medicine at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total score Change from Baseline of Asthma Control Test (time frame: Measured during the 6 week treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01931696, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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