UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015346 |
|---|---|
| Receipt number | R000017849 |
| Scientific Title | Autonomic nervous response to the treatment of moxibustion on the acupuncture point (Xinshu, BL15) with a pressure pain |
| Date of disclosure of the study information | 2014/10/06 |
| Last modified on | 2015/11/13 09:38:12 |
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Basic information
Public title
Autonomic nervous response to the treatment of moxibustion on the acupuncture point (Xinshu, BL15) with a pressure pain
Acronym
Autonomic nervous response to the treatment of moxibustion on the acupuncture point (Xinshu, BL15) with a pressure pain
Scientific Title
Autonomic nervous response to the treatment of moxibustion on the acupuncture point (Xinshu, BL15) with a pressure pain
Scientific Title:Acronym
Autonomic nervous response to the treatment of moxibustion on the acupuncture point (Xinshu, BL15) with a pressure pain
Region
| Japan |
Condition
Condition
Upper back Pain, Stress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the difference of autonomic nervous response to the treatment of moxibustion on the acupuncture point with or without a pressure pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability
Key secondary outcomes
Skin surface temperature
Deep temperature
Skin blood flow
Pupillary reaction to light
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
Moxibustion
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
Key exclusion criteria
Those who feel uncomfortable during the study
Those who are judged inappropriate for the cooperation of this study by the investigator in charge
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ito |
Organization
Kitasato University Oriental Medicine Research Center
Division name
Department of Acupuncture and Moxibustion, Center for EVIDENCE-BASED-MEDICINE
Zip code
Address
5-9-1 SHIROKANE, MINATO-KU, TOKYO
TEL
03-5791-6164
yuichi.i@insti.kitasato-u-ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Ito |
Organization
Kitasato University Oriental Medicine Research Center
Division name
Center for EVIDENCE-BASED-MEDICINE
Zip code
Address
5-9-1 SHIROKANE, MINATO-KU, TOKYO
TEL
03-5791-6164
Homepage URL
yuichi.i@insti.kitasato-u-ac.jp
Sponsor or person
Institute
Kitasato University Oriental Medicine Research Center
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Oriental Medicine Research Center
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 06 | 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
| 2014 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017849
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
