UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Plant Extract on Improving Minor Ailments: An Exploratory Study
Acronym	Effects of Plant Extract on Improving Minor Ailments: An Exploratory Study
Scientific Title	Effects of Plant Extract on Improving Minor Ailments: An Exploratory Study
Scientific Title:Acronym	Effects of Plant Extract on Improving Minor Ailments: An Exploratory Study
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comprehensive search for clinical benefits associated with 4 weeks daily intake of a plant extract on improving minor ailments.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Presenteeism
Key secondary outcomes	Sleeping record, electroencephalogram during sleeping, heart rate variability, intestinal flora, urinary oxidative stress markers (8-hydroxy-2'-deoxyguanosine (8-OHdG), 8-isoprostane), survey on subjects' sleeping and mental and physical conditions.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Daily ingestion 10 tablets of active test food for 4 weeks.
Interventions/Control_2	Daily ingestion 10 tablets of placebo test food for 4 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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects who agree to participate in this study with a written informed consent. 2. Japanese male and female between 30 and 50 years old, after obtaining consent. 3. Subjects without serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring report to the authorities. 4. Subjects with fatigue by work.
Key exclusion criteria	1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders. 2. Subjects with unusually high and/or low blood pressure and/or abnormal body measurement data and/or abnormal hematological data. 3. Subjects with severe anemia. 4. Subjects who are at risk of having allergic reactions to 28 food allergic substances or materials of test food. 5. Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 6. Pre- or post-menopausal women complaining of obvious physical changes. 7. Pregnant, lactating women or women who expect to be pregnant during this study. 8. Subjects who regularly eat which contains materials of test foods within 4 weeks, prior to the current study. 9. Subjects who regularly take medicine, functional foods, and/or supplements which would affect sleep and/or stress. 10. Subjects who plan to travel abroad during this study. 11. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study, or subjects who do not agree not to donate blood during this study. 12. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study, or intend to participate in order clinical trials after obtaining consent to participate in this study. 13. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name NISHIHIRA
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4411
Email	nishihira@do-johodai.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name NISHIHIRA
Organization	Hokkaido Information University
Division name	Health Information Science Center
Zip code	069-8585
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL	011-385-4430
Homepage URL
Email	nishihira@do-johodai.ac.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

Funding Source
Organization	National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Agriculture and Food Research Organization
Name of secondary funder(s)	Meiji Co., Ltd.

IRB Contact (For public release)
Organization	The ethics committee of Hokkaido Information University
Address	59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel	011-385-4411
Email	soumu@do-johodai.ac.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	北海道情報大学　保健センター（北海道）

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 09 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	2020 Year 03 Month 25 Day
Date of IRB	2020 Year 03 Month 25 Day
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2020 Year 11 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 07 Day
Last modified on	2021 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046662