UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027295 |
|---|---|
| Receipt number | 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 12:23:59 |
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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
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
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031273
