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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044186
Receipt No. R000050439
Scientific Title A Study on the Effect of Food Containing Plant Extract on QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2021/05/14
Last modified on 2021/11/10

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Basic information
Public title A Study on the Effect of Food Containing Plant Extract on QOL
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym A Study on the Effect of Food Containing Plant Extract on QOL
Scientific Title A Study on the Effect of Food Containing Plant Extract on QOL
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym A Study on the Effect of Food Containing Plant Extract on QOL
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of food containing plant extract on QOL
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL questionnaire
Key secondary outcomes complexion

Base
Study type Interventional

Study design
Basic design Parallel
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 Treatment
Type of intervention
Food
Interventions/Control_1 Foods containing plant extract, 4 weeks consumption
Interventions/Control_2 Foods not containing plant extract, 4 weeks consumption
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy Japanese males and females aged 20 to 64 years-old.
2)Subjects who tend to feel tired easily in daily life.
3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria Subjects (who)
1)are judged by doctors to have a high probability of chronic fatigue syndrome.
2)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease).
3)have a chronic disease and use medications.
4)contract or have a surgical history of digestive disease affecting digestion and absorption.
5)may have allergy to test foods.
6)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week.
7)can't stop drinking from 2 days before each measurement.
8) smoke 10 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed.
9)use drugs, supplements, or functional foods associated with fatigue recovery.
10)are shiftworker, midnight worker and/or hard worker.
11)have regular hard exercise.
12) are pregnant or breast-feeding or planned to become pregnant during the study period.
13) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
14)are participating in or willing to participate in other clinical studies.
15)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kayoko
Middle name
Last name Numano
Organization Ebisu Ray Clinic, Shinkoukai Medical Corporation
Division name Dermatology
Zip code 150-0013
Address 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL 03-6277-3917
Email kaco@yahoo.co.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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 General Incorporated Association Clinical Research Review Center
Address 2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel 090-3547-6398
Email crrctakashima@kpd.biglobe.ne.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
2021 Year 05 Month 14 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
2021 Year 04 Month 12 Day
Date of IRB
2021 Year 04 Month 21 Day
Anticipated trial start date
2021 Year 05 Month 15 Day
Last follow-up date
2021 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 12 Day
Last modified on
2021 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050439

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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