Effectiveness of Acupuncture for Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917215
• Other study ID #: KE0802
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: July 29, 2009
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: Korea Institute of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Allergy & Respiratory System, Department of Oriental Internal Medicine, Kyunghee medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of weekly average of peak expiratory flow (PEF)values in the morning at home		From 1 week of run-in period to the 4th week of treatment	No
Secondary	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)	No