UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017609 |
|---|---|
| Receipt number | 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 | 2021/05/22 09:42:43 |
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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
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
mikisuke@toneyama.go.jp
Sponsor or person
Institute
National Hospital Organization Toneyama National Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 21 | Day |
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
| 2021 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020397
