UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038236 |
|---|---|
| Receipt number | R000043586 |
| Scientific Title | Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic. |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2020/10/08 10:20:06 |
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Basic information
Public title
Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Acronym
Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Scientific Title
Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Scientific Title:Acronym
Effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to effects of acupuncture stimulation on the head on the number of responses of mental arithmetic and the number of correct answers of mental arithmetic.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of correct answers of mental arithmetic.
Key secondary outcomes
Cerebral blood flow in the prefrontal cortex
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control
Interventions/Control_2
acupuncture
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women over 16 years of age.
Those who can attend the research site during the research period.
Those who can obtain written consent for participation in this research.
Those who have not participated in other experiments within 3 months.
Key exclusion criteria
Patients who are outpatients or taking medications for underlying diseases (diabetes, heart disease, kidney disease, liver disease, hyponatremia, hypertension that is difficult to treat, etc.).
Person receiving medication.
Those with extremely short sleep (less than 5 hours a day) and those with long sleep (more than 10 hours a day).
Those who have reversed day and night due to work or part-time work.
Person who receives excessive physical and mental stress.
Persons who are treated for autoimmune disease, chronic inflammatory disease, allergic disease, and cancer.
Those who practice excessive smoking and excessive alcohol consumption and those whose diet is extremely irregular.
Person with remarkable abnormality by blood pressure, blood test, urine test.
Those who performed 400 ml blood donation within 12 weeks of the experiment start, 200 ml blood donation within 4 weeks, and the component blood donation within 2 weeks.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Hisajima |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
hisajimatatsuya@mac.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Suzuki |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
TEL
03-5843-4860
Homepage URL
s.tky0706@gmail.com
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei University
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
Teikyo Heisei University
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
Tel
03-5843-4860
s.tky0706@gmail.com
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
| 2019 | Year | 12 | Month | 01 | 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
| 2019 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2020 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043586
