UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057691 |
|---|---|
| Receipt number | R000065887 |
| Scientific Title | A Clinical trial on the Effects of test substance GL-2 on Posture and Fatigue : single blinded study |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2025/04/21 16:57:00 |
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Basic information
Public title
A Clinical trial on the Effects of test substance GL-2 on Posture and Fatigue
Acronym
A Clinical trial on the Effects of test substance GL-2 on Posture and Fatigue
Scientific Title
A Clinical trial on the Effects of test substance GL-2 on Posture and Fatigue : single blinded study
Scientific Title:Acronym
A Clinical trial on the Effects of test substance GL-2 on Posture and Fatigue
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of test substance GL-2 on posture and fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantification of standing posture after 2 weeks(image analysis)
Key secondary outcomes
Subjective evaluation after 2 weeks (fatigue)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
2-week intervention of test substance GL-2
Interventions/Control_2
non-intervention(2-week)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy males and females aged 20 to 69 years-old.
2.Those who frequently feel foot fatigue or have flat feet
3.Subjects who stand or walk while wearing shoes for more than 5 hours per day, at least 5 days a week.
4.Subjects who walk more than 5,000 steps per day
5.Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects (who)
1. are/might be pregnant or lactating during the current study periods.
2. spend less than 5 hours per day wearing shoes (Subjects who switch to sandals or other types of non-shoe footwear during the day).
3. do not experience fatigue in their legs in daily life.
4. are currently undergoing outpatient treatment for disorders of the foot or leg, or who have previously undergone foot surgery.
5. legs are affected by severe pain or disability.
6. are prohibited from engaging in physical activity by their physician.
7. have severe cardiac, respiratory, circulatory disorders, or other serious disease.
8. ability to exercise is restricted due to injuries or disabilities of the lower extremities.
9. are using specific medications that affect symptoms of the lower extremities.
10. have a smoking habit.
11. can't stop drinking from 2 days before each measurement.
12. have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week.
13. are under treatment for or have a history of drug addiction and/or alcoholism.
14. have participated in other clinical studies within one month prior to obtaining informed consent, or plan to participate in other studies.
15. are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2025 | Year | 04 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065887
