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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017609
Receipt No. R000020397
Scientific Title Clinical effect of acupuncture on patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2015/05/25
Last modified on 2015/05/28

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Basic information
Public title Clinical effect of acupuncture on patients with chronic obstructive pulmonary disease
Acronym Clinical trial of acupuncture in COPD patients
Scientific Title Clinical effect of acupuncture on patients with chronic obstructive pulmonary disease
Scientific Title:Acronym Clinical trial of acupuncture in COPD patients
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of acupuncture for three months on exercise tolerance and QOL of patients with COPD (Stage II - IV).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peak oxygen uptake
Endurance time
SGRQ score
Key secondary outcomes Borg scale
O2-pulse
VD/VT
VE/Vo2
VE/Vco2
Respiratory muscle strength
Plasma concentration of norepinephrine
Body weight
CAT score
mMRC dyspnea scale
Pulmonary function test (Mostgraph, Expiratory FeNo)
24-h heart rate variability
Daily physical activities measured using Activision marker
Skeletal muscle mass, bone mass, and fat measured using Dual-Energy X-ray Absorptiometry (DEXA)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Acupuncture
Once weekly for 12 weeks
Interventions/Control_2
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
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)COPD determined according to diagnostic criteria and classified as stage II or more using the GOLD criteria. Those rated as grade >= 1 according to modified Medical Research Council dyspnea scale (mMRC).
2)Aged > 40 years
3)Stable patients able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation.
4)Signed agreement to participate in the study
Key exclusion criteria 1)Malignant tumors
2)Active infectious disease
3)Severe heart disease
4)Hepatic failure
5)Renal failure
6)Drug regimen changed during clinical trials
7)Participation in pulmonary rehabilitation programs
8)Judged inadequate to participate in the study by their physicians
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Miki
Organization National Hospital Organization Toneyama National Hospital
Division name Laboratory Chief, Laboratory of Respiratory Science, Division of Clinical Research
Zip code
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL 06-6853-2001
Email mikisuke@toneyama.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Miki
Organization National Hospital Organization Toneyama National Hospital
Division name Laboratory Chief, Laboratory of Respiratory Science, Division of Clinical Research
Zip code
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL 06-6853-2001
Homepage URL
Email mikisuke@toneyama.go.jp

Sponsor
Institute National Hospital Organization Toneyama National Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Clinical Research from National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 独立行政法人 国立病院機構 刀根山病院

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 18 Day
Last modified on
2015 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020397

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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