NCT00917215CompletedNot Applicable
Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial
Korea Institute of Oriental Medicine1 site in 1 country45 target enrollmentStarted: September 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change of weekly average of peak expiratory flow (PEF)values in the morning at home
Study Overview
Brief Summary
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)?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active acupuncture
Experimental
Intervention: Disposable stainless steel acupuncture (0.2mmx4mm) (Device)
Sham acupuncture
Sham Comparator
Intervention: Disposable stainless steel acupuncture (0.2mmx4mm) (Device)
Waiting list control
No Intervention
Outcomes
Primary Outcomes
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
- Forced expiratory volume in 1 second (FEV1) Baseline Dyspnea Index (BDI) Transition Dyspnea Index (TDI) Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA)(Baseline and 2 weeks, 4 weeks, 6 weeks after Baseline (BDI for baseline only, TDI for 2, 4, and 6 weeks after baseline))
Investigators
Study Sites (1)
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