UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for safety evaluation and immune effect of excess consumption of plant extract for 4 weeks.
Title of the study (Brief title)	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	Suguru Fujiwara
Organization	CPCC Co., Ltd.
Division name	Clinical Research Planning Department
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	Suguru Fujiwara
Organization	CPCC Co., Ltd.
Division name	Clinical Research Planning Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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