UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053241 |
|---|---|
| Receipt number | R000060694 |
| Scientific Title | Effects of treatment on fatigue improvement for the purpose of recovery from fatigue |
| Date of disclosure of the study information | 2023/12/27 |
| Last modified on | 2024/03/05 09:22:13 |
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Basic information
Public title
Effects of treatment on fatigue improvement for the purpose of recovery from fatigue
Acronym
Effects of treatment on fatigue improvement for the purpose of recovery from fatigue
Scientific Title
Effects of treatment on fatigue improvement for the purpose of recovery from fatigue
Scientific Title:Acronym
Effects of treatment on fatigue improvement for the purpose of recovery from fatigue
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on recovery from fatigue by comparing psychological indices before and after treatment on fatigue improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological indices (VAS, POMS)
Key secondary outcomes
Autonomic nervous system measurement, urine analysis, saliva analysis, muscle hardness measurement, surface body temperature measurement
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
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Perform treatment on fatigue improvement (single implementation)
Interventions/Control_2
Perform treatment on fatigue improvement (single implementation)
Interventions/Control_3
Perform treatment on fatigue improvement (single implementation)
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged between 30 and 59
Key exclusion criteria
1) Subjects who are using a cardiac pacemaker
2) Subjects who are suffering from hypertension and taking antihypertensive drugs
3) Subjects who are pregnant, or are breastfeeding
4) Subjects who have a reason for not being able to undergo the treatment performed in this study, or who are prohibited from doing so by a physician
5) Subjects who are participating in other studies (trials) on fatigue recovery
6) Subjects who judged as unsuitable for the study by the investigator for other reasons
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
Ezaki Glico Co., Ltd.
Division name
Wellness Innovation Business Division
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
TEL
+81-6-6477-8793
kei.yui@glico.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, 112-0002, Japan
TEL
+81-3-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fatigue Science Laboratory Ethical Revie Committee
Address
7-4-21, No.2 Hawk Crescent Bldg., Nishinakajima, Yodogawa-ku, Osaka, 532-0011, Japan
Tel
+81-6-6308-1190
kuni@fatigue.co.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
| 2023 | Year | 12 | Month | 27 | 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
| 2023 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060694
| 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 |
