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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030779
Receipt No. 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 2018/01/12

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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
Email 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
Email jacta@usjri.com

Sponsor
Institute Japan clinical trial association
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 12 Day
Last follow-up date
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
2018 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035137

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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