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Recruitment status Completed
Unique ID issued by UMIN UMIN000001277
Receipt No. R000001554
Official scientific title of the study The effect of Acupuncture in the treatment of chronic obstructive pulmonary disease (COPD Acupuncture Trial: CAT).
Date of disclosure of the study information 2008/07/30
Last modified on 2009/08/03

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Basic information
Official scientific title of the study The effect of Acupuncture in the treatment of chronic obstructive pulmonary disease (COPD Acupuncture Trial: CAT).
Title of the study (Brief title) To evaluate of clinical effect of acupuncture treatment of exercise in COPD
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improvement effect of dyspnea on exercise in COPD patient (Stage II-IV) with acupuncture for 3 months treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Modified Borg dyspnea scale after the 6-minute walk test.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Acupuncture group
once a week for 12 weeks
Interventions/Control_2 Sham acupuncture group
once a week for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patient diagnosed as COPD by physician.
2.Patient who were able to visit as outpatient.
3.Patient who had been judged as stable condition by the physician.
4.Those who were rated as grade 2 or more according to MRC criteria.
5.Those who were classified as stage II or more advanced to GOLD criteria.
Key exclusion criteria 1.Patient judged to be not suitable because of existence of skin disorder by physician.
2.Those who have heart failure (The cor pulmonale is excluded), collagen disease (RA and PM/DM, etc.), malignant tumor, or severe mental disorders.
3.The patient who were in concurrent respiratory rehabilitation program.
Target sample size 60

Research contact person
Name of lead principal investigator Mishima Michiaki
Organization Graduate school of medicine kyoto university
Division name Department of respiratory medicine
Address 54 Kawahara Shogoin Sakyo-ku Kyoto city Kyoto Japan
TEL
Email

Public contact
Name of contact person Suzuki Masao
Organization Meiji University of Integrative Medicine
Division name Department of clinical acupuncture and moxibustion
Address Honoda Hiyoshi-cho Nantan city Kyoto Japan
TEL 0771-72-1181
Homepage URL
Email

Sponsor
Institute Graduate school of medicine kyoto university department of respiratory medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization The Japan society of acupuncture and moxibution
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 30 Day

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 04 Month 11 Day
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 05 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results Main outcome:
The Borg scale scores improved significantly in the acupuncture group after 12 weeks, and this positive change was significantly than in the control group.
Other related information

Management information
Registered date
2008 Year 07 Month 30 Day
Last modified on
2009 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001554


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