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Effectiveness of Acupuncture for Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917215
First Posted: June 10, 2009
Last Update Posted: July 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korea Institute of Oriental Medicine
  Purpose
What is the trend of changes in asthmatic patients' daily peak expiratory flow (PEF) variability, pulmonary function, and quality of life (QOL) with acupuncture treatment on specific acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1) compared with minimal acupuncture treatment (sham control group) on non-acupoints, and no acupuncture treatment (waiting list control group)?

Condition Intervention
Asthma Device: Disposable stainless steel acupuncture (0.2mmx4mm)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial

Resource links provided by NLM:


Further study details as provided by Korea Institute of Oriental Medicine:

Primary Outcome Measures:
  • Change of weekly average of peak expiratory flow (PEF)values in the morning at home [ Time Frame: From 1 week of run-in period to the 4th week of treatment ]

Secondary Outcome Measures:
  • Forced expiratory volume in 1 second (FEV1) Baseline Dyspnea Index (BDI) Transition Dyspnea Index (TDI) Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA) [ Time Frame: Baseline and 2 weeks, 4 weeks, 6 weeks after Baseline (BDI for baseline only, TDI for 2, 4, and 6 weeks after baseline) ]

Estimated Enrollment: 45
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active acupuncture Device: Disposable stainless steel acupuncture (0.2mmx4mm)

For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks.

For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks.

Sham Comparator: Sham acupuncture Device: Disposable stainless steel acupuncture (0.2mmx4mm)

For active acupuncture group, needles were inserted into nine acupoints (CV22 and bilateral LU5, ST40, BL13, EXB1)with De-qi three times a week for 4 weeks.

For sham acupuncture group, Nine non-acupoints corresponded with each active acupoint were treated with minimal penetration into skin three times a week for 4 weeks.

No Intervention: Waiting list control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 19-70 years
  • at least 12% improvement in forced expiratory volume in one second (FEV1)after the administration of short acting beta2 agonist.
  • at least one typical asthmatic symptom
  • using more than one routine anti-asthmatic medicine

Exclusion Criteria:

  • acupuncture for asthma within 12 months of the study
  • emergency department visit within one month of the study
  • hospitalization for asthma within three months of the study
  • severe upper respiratory tract infections within six weeks of the study
  • systemic infections, cancers, autoimmune disorders, cardiac failures, myofacial infarcts,angina pectoris, renal failures or hepato-biliary diseases
  • smoke more than ten cigarettes per day
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917215


Locations
Korea, Republic of
Division of Allergy & Respiratory System, Department of Oriental Internal Medicine, Kyunghee medical center
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Korea Institute of Oriental Medicine
  More Information

Responsible Party: Sun-Mi Choi, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00917215     History of Changes
Other Study ID Numbers: KE0802
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: July 30, 2009
Last Verified: July 2009

Keywords provided by Korea Institute of Oriental Medicine:
Asthma
Acupuncture
Pulmonary function
Quality of life

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases