UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Ingestion of Perilla Extract for 8 weeks on Pollinosis Caused by Japanese White Birch(Betula platyphylla var. japonica).: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group.
Title of the study (Brief title)	Effect of Ingestion of Perilla Extract for 8 weeks on Pollinosis Caused by Japanese White Birch.
Region	Japan

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

Objectives
Narrative objectives1	To prove clinical benefits associated with 8 week ingestion of perilla extract on pollinosis caused by japanese white birch. Additionally to examine improvement of defecation status in order to evaluate the comprehensive effects of perilla extract.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	VAS questionnaire assessed pollinosis, questionnaire assessed pollinosis, white birch pollen-specific IgE
Key secondary outcomes	non-specific IgE, Eosinophil, TARC, questionnaire assessed defecation status, VAS questionnaire assessed defecation status, PSQ questionnaire

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	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of capsules containing perilla extract daily for 8 weeks.
Interventions/Control_2	Ingestion of placebo capsules daily for 8 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Subjects who have seasonal allergic symptoms (runny nose, sneezing, nose clogging, itching of the nose, itching of the eyes, watery eyes etc.) from April to June. 2.Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria	1.Subjects who received a diagnosis from a doctor for an allergic disease in the past year. 2.Subjects who are very heavy hay fever symptoms with pollinosis questionnaire. 3. Subjects such as acute rhinitis, sinusitis. 4.Subject who have a history of cancer of the digestive system or those who are currently treated for medication. 5.Subject who have digestive disorders. 6.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 7.Subjects with major surgical history relevant to the digestive system. 8.Subjects with unusually high, low blood pressure, abnormal hematological data, severe anemia. 9.Pre- or post-menopausal women complaining of obvious physical changes. 10.Subjects who are at risk of having allergic reactions to drugs or perilla frutescens or gelatin. 11.Subject who use medicines prescribed for medical institutions for treatment of birch pollen allergy. 12.Subject who regularly take over-the-counter medicine to alleviate seasonal allergy-like symptoms. 13.Subject who regularly take prescription drugs and over-the-counter medicine for the purpose of improving bowel movements. 14.Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 15.Subject who can not stop taking intake of health foods and supplements or shiso juice during the examination period. 16.Excess smokers and regulars alcohol addicts or subjects with eating disordered lifestyle. 17.Subjects who donated a predetermined amount of blood in a given period. 18.Pregnant or lactating women or women who expect to be pregnant during this study. 19.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 20.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size	32

Research contact person
Name of lead principal investigator	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
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	Amino Up Chemical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	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	2017 Year 05 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 27 Day
Anticipated trial start date	2017 Year 05 Month 12 Day
Last follow-up date	2017 Year 07 Month 23 Day
Date of closure to data entry	2017 Year 10 Month 03 Day
Date trial data considered complete	2017 Year 10 Month 04 Day
Date analysis concluded	2018 Year 03 Month 29 Day

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

Management information
Registered date	2017 Year 05 Month 10 Day
Last modified on	2018 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031273