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Completed

NCT Number: NCT00917215

Effectiveness of Acupuncture for Asthma

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)?

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Allergy & Respiratory System, Department of Oriental Internal Medicine, Kyunghee medical center

Seoul, 130-702, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disposable stainless steel acupuncture (0.2mmx4mm)

Device

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.

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Korea Institute of Oriental Medicine

Other Gov

Registry information

Official study title

Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 10, 2009
Registry last updated
Jul 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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