UMIN-CTR Clinical Trial


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Recruitment
status
Completed
Unique trial Number : UMIN000001277
Title of the study : The effect of Acupuncture in the treatment of chronic obstructive pulmonary disease (COPD Acupuncture Trial: CAT).
Date of formal registration
(=Date of ICMJE and WHO compliant trial information registration and disclosure)
: 2008/07/30
Date and time of last update : 2009/08/03 12:54:56

This page includes information on clinical trials registered in UMIN clinical trial registed system.
We don't aim to advertise certain products or treatments.

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


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


Base
Item Value
Study type Interventional


Study design
Item Value
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
Item Value
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


Eligibility
Item Value
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
Item Value
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
Item Value
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 +81-771-72-1181
Homepage URL
Email


Sponsor
Item Value
Name of primary sponsor Graduate school of medicine kyoto university department of respiratory medicine

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
Item Value
Source of funding The Japan society of acupuncture and moxibution
Category of Org. Non profit foundation
Nation of funding Japan


Other related organizations
Item Value
Name of secondary sponsor(s)
Name of secondary funder(s)


Secondary study IDs
Item Value
Secondary study IDs NO
Secondary study ID_1
Org. issuing Secondary study ID_1
Secondary study ID_2
Org. issuing Secondary study ID_2
IND to MHLW


Institutions
Item Value
Institutions


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


Related information
Item Value
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


Item Value
Date of registration 2008/07/30
Date of last update 2009/08/03 12:54:56


Link to view
URL(Japanese) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000001554&type=summary&language=J
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000001554&type=summary&language=E
This page includes information on clinical trials registered in UMIN clinical trial registed system.
We don't aim to advertise certain products or treatments.