UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031378
Receipt No. R000035771
Scientific Title Study of beneficial effect of continuous algal food intake on the symptoms of Japanese ceder pollinosis a randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2019/02/19
Last modified on 2019/02/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study of beneficial effect of continuous algal food intake on the symptoms of Japanese ceder pollinosis
a randomized, double-blind, placebo-controlled, parallel-group study
Acronym Study of beneficial effect of continuous algal food intake on the symptoms of Japanese ceder pollinosis
Scientific Title Study of beneficial effect of continuous algal food intake on the symptoms of Japanese ceder pollinosis
a randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym Study of beneficial effect of continuous algal food intake on the symptoms of Japanese ceder pollinosis
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Clinical immunology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of beneficial effect of continuous algal food intake on the symptoms of Japanese ceder pollinosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The symptoms of Japanese cedar pollinosis after starting consumption of test food
Key secondary outcomes Results of blood test
feeling 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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 algal food intake
Interventions/Control_2 placebo control food intake
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 agree to participate in the current study with a written informed consent
2)Japanese who are 20 or more to less than 65 years old
3)Subjects who have symptoms of Japanese cedar pollinosis
4)Subjects who live in Osaka Prefecture, Kyoto City, Amagasaki City, Itami City, Nishinomiya City, Ashiya City, Kobe City
Key exclusion criteria 1)Individuals using medical products
2)Individuals who have a history or merger of serious diseases of liver disease or renal, endocrine, cardiovascular, gastrointestinal, lung, blood, metabolism
3)Individuals who have had surgery on the gastrointestinal tract
4)Individuals who have received treatment for hyposensitization therapy in the past
5)Individuals judged inappropriate for the study by the principal
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohno Naohito
Organization Tokyo University of Pharmacy and Life Sciences
Division name Laboratory for Immunopharmacology of Microbial Products
Zip code
Address 1432-1 Horinouchi, Hachioji, Tokyo 192-0392 Japan
TEL 042-676-5561
Email ohnonao@toyaku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ootani Kazuyoshi
Organization KOBELCO ECO-SOULUTIONS CO.,LTD
Division name Algae Business Promotion Dept.
Zip code
Address 4-78, 1-chome, Wakinohama-cho, Chuo-ku, Kobe 651-0072, Japan
TEL 078-232-8223
Homepage URL
Email k.otani@kobelco-eco.co.jp

Sponsor
Institute MARUISHILABO CORPORATION
Institute
Department

Funding Source
Organization KOBELCO ECO-SOULUTIONS 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
2019 Year 02 Month 19 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
2018 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.