UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034181 |
|---|---|
| Receipt number | R000038969 |
| Scientific Title | Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers |
| Date of disclosure of the study information | 2018/09/25 |
| Last modified on | 2021/04/12 14:45:16 |
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Basic information
Public title
Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Acronym
Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Scientific Title
Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Scientific Title:Acronym
Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Currently, health problems of workers are becoming a big social concern. From the past results of the labor health surveys and questionnaire surveys on fatigue, it can be suggested that many workers have feelings of anxiety about health due to fatigue of mind and body, accumulation of fatigue, stress due to work, and various subjective symptoms.
Fatigue may lead to a decrease in work efficiency, concentration, and memory ability, while to an increase in mistakes, plausibly causing lifestyle diseases, depression, death from overwork and the like. Effectiveness of acupuncture and moxibustion treatment in improving physical symptoms such as asthenopia, stiff neck/shoulder, general malaise frequently complained by workers with fatigue has also been reported. From the features of acupuncture and moxibustion therapy there is a possibility that it is effective against various symptoms such as fatigue and stress of mind and body, If we can prove the usefulness of acupuncture and moxibustion treatment, it will be meaningful from the viewpoint of health management. In this study, therefore, we examine the usefulness of acupuncture and moxibustion treatment for physical fatigue and mental fatigue in workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale
Key secondary outcomes
GHQ-12
Salivary cortisol
Saliva amylase
Physical symptom score
SF-36 Standard Edition
WHO Health and Work Performance Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acupuncture and Moxibustion
Interventions/Control_2
Press Needles
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Person with physical fatigue and mental fatigue
Key exclusion criteria
1. Person who underwent consecutive treatments in a psychiatric clinic/hospital, took psychotropic drugs or had such medical history.
2. Person who had a change in living environment including working conditions and medication status or the past one month or less
3. Person with the medical abnormality that may cause fatigue
4. Person in whom a disease or abnormality was discovered and person who had a change in lifestyle or living environment during the study period
5. Female worker in the childcare period
6. Person who presents with a symptom of severe dysmenorrhea or premenstrual syndrome every month
7. Person with menopausal disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL
+08-3-6703-7000
sakai@tau.ac.jp
Public contact
Name of contact person
| 1st name | Arisa |
| Middle name | |
| Last name | Muko |
Organization
Tokyo Ariake University of Medical and Health Sciences Graduate school
Division name
Doctor's Program of Health Sciences
Zip code
135-0063
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL
+08-3-6703-7000
Homepage URL
arisa71cq@gmail.com
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical and Health Sciences
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
Tokyo Ariake University of Medical and Health Sciences IRB
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel
+08-3-6703-7000
akiyama@tau.ac.jp
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
| 2018 | Year | 09 | 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
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 18 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038969
| Research Plan | |
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| 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 |
