AsthmaNCT00917215
Effectiveness of Acupuncture for Asthma
A study testing Disposable stainless steel acupuncture (0.2mmx4mm) in people with Asthma, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Disposable stainless steel acupuncture (0.2mmx4mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Apr 2009
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Allergy & Respiratory System, Department of Oriental Internal Medicine, Kyunghee medical center
Seoul, 130-702
About this study
Official title: Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial
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)?
- Conditions
- Asthma
- Being tested
- Disposable stainless steel acupuncture (0.2mmx4mm)
- Keywords
- Asthma, Acupuncture, Pulmonary function, Quality of life
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active acupuncture | Experimental | Not described Receives: Device: Disposable stainless steel acupuncture (0.2mmx4mm) |
| Sham acupuncture | Sham comparator | Not described Receives: Device: Disposable stainless steel acupuncture (0.2mmx4mm) |
| Waiting list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of weekly average of peak expiratory flow (PEF)values in the morning at home
Measured: 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)
Measured: Baseline and 2 weeks, 4 weeks, 6 weeks after Baseline (BDI for baseline only, TDI for 2, 4, and 6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917215
- Sponsor's protocol ID
- KE0802
- Status last verified
- Jul 2009
- First submitted
- 9 Jun 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture for Asthma: A Randomized, Sham-acupuncture and Waiting-list Controlled Trial
- ClinicalTrials.gov ID
- NCT00917215
- Acronym / sponsor ID
- KE0802
- Conditions
- Asthma
- Keywords
- Asthma, Acupuncture, Pulmonary function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Study start
- Sep 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active acupuncture | Experimental | Device: Disposable stainless steel acupuncture (0.2mmx4mm) |
| Sham acupuncture | Sham comparator | Device: Disposable stainless steel acupuncture (0.2mmx4mm) |
| Waiting list control | No intervention | – |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active acupuncture, Sham acupuncture |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable stainless steel acupuncture (0.2mmx4mm) in people with Asthma, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
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 4 inclusion and 6 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 30 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2009.