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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030702
Receipt No. R000035052
Scientific Title A study for safety evaluation and immune effect of excess consumption of plant extract for 4 weeks.
Date of disclosure of the study information 2018/01/05
Last modified on 2018/01/05

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Basic information
Public title A study for safety evaluation and immune effect of excess consumption of plant extract for 4 weeks.
Acronym A study for safety evaluation and immune effect of excess consumption of plant extract for 4 weeks.
Scientific Title A study for safety evaluation and immune effect of excess consumption of plant extract for 4 weeks.
Scientific Title:Acronym A study for safety evaluation and immune effect of excess consumption of plant extract for 4 weeks.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and immune effect evaluation when healthy adults consume excess amount of the test food in 4 consecutive weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NK cells activity
Key secondary outcomes Secondary outcomes: nonspecific IgE, allergen-specific IgE (for 8 allergens), IgD, IgG, IgM, Japan Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ).
Safety evaluation items: physiological examination, hematological examination, blood biochemical examination, urine examination, presence or absence of, type of, severity of and frequency of side effects and adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake 180 mL of test food a day divided 3 times (60mL each) four consecutive weeks.
Interventions/Control_2
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)Male and female aged over 20 years old when consent acquisition.
(2)Subjects who can intake test food every day.
(3)Subjects who notice themselves as they are perennial allergic rhinitis.
(4)Subjects giving written informed consent.
Key exclusion criteria (1) Subjects who have treated or taken medicine for perennial allergic rhinitis from 4 weeks short the end of the study.
(2) Subjects who planning some treatment during the examination period.
(3) Subjects who having Food for Specified Health Uses (FOSHU) and/or health food.
(4) Pregnant or expected pregnant, and lactating women.
(5) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney.
(6) Subjects who excessive alcohol intake.
(7) Subjects who have smoking habit.
(8) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(9) Subjects who have previous medical history of drug and/or food, allergy, especially for Shiso leaf.
(10) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(11) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(12) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(13) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(14) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(16) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suguru Fujiwara
Organization CPCC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Fujiwara
Organization CPCC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Emotent 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 05 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 07 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 11 Month 19 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2018 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035052

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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