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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027295
Receipt No. R000031273
Scientific Title 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.
Date of disclosure of the study information 2017/05/11
Last modified on 2018/07/20

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Basic information
Public title 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.
Acronym Effect of Ingestion of Perilla Extract for 8 weeks on Pollinosis Caused by Japanese White Birch.
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
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
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
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)

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 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

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 04 Month 27 Day
Date of IRB
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

Other
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

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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