UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030779 |
|---|---|
| Receipt number | R000035137 |
| Scientific Title | Effect of food containing plant extract on alleviating fatigue: a randomized, double-blind, placebo-controlled, crossover trial |
| Date of disclosure of the study information | 2018/01/12 |
| Last modified on | 2020/03/16 10:59:39 |
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Basic information
Public title
Effect of food containing plant extract on alleviating fatigue: a randomized, double-blind, placebo-controlled, crossover trial
Acronym
Effect of food containing plant extract on alleviating fatigue
Scientific Title
Effect of food containing plant extract on alleviating fatigue: a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym
Effect of food containing plant extract on alleviating fatigue
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate alleviation effect of fatigue by ingestion of food containing plant extract consecutively for subjects who feel temporal fatigue versus placebo control.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS (subjective appraisal of fatigue), before and after 2 weeks of consecutive ingestion of food
Key secondary outcomes
Sefety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of food containing plant extract for 2 consecutive weeks
Interventions/Control_2
Ingestion of placebo for 2 consecutive weeks
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
| 59 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females between 20 and 59 years of age inclusive
2. Subjects who feel temporal fatigue
Key exclusion criteria
1. Subjects with food allergies
2. Subjects who are pregnant or lactating
3. Subjects who consume medicinal product which may influence the study
4. Subjects who consume food which may influence the study
5. Subjects with chronic fatigue syndrome
6. Subjects affected by the other disease
7. Subjects who are judged as unsuitable for the study by the principal investigator for the other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatomo Najima |
Organization
Japan clinical trial association
Division name
N.A.
Zip code
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
03-6457-4666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kaneko |
Organization
Japan clinical trial association
Division name
N.A.
Zip code
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
03-6457-4666
Homepage URL
jacta@usjri.com
Sponsor or person
Institute
Japan clinical trial association
Institute
Department
Personal name
Funding Source
Organization
TAHEEBO JAPAN 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
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
| 2018 | Year | 01 | Month | 12 | 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
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | 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 | 01 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035137
