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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029086
Receipt No. R000033198
Scientific Title Effects of a Test Food for Reducing Discomfort of Eyes or Nose
Date of disclosure of the study information 2017/09/12
Last modified on 2017/12/14

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Basic information
Public title Effects of a Test Food for Reducing Discomfort of Eyes or Nose
Acronym Effects of a Test Food for Reducing Discomfort of Eyes or Nose
Scientific Title Effects of a Test Food for Reducing Discomfort of Eyes or Nose
Scientific Title:Acronym Effects of a Test Food for Reducing Discomfort of Eyes or Nose
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate effect of a test food for reducing discomfort of eyes and nose and its safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Indexes for allergic rhinitis (grading the severity of allergic rhinitis [Week 0, 4, 8, 12]; grading of local findings [Week 0, 4, 8, 12]; effect measurement [Week 12]; Japan Rhinitis Quality of Life Questionnaire No. 1 [Week 0, 2, 4, 6, 8, 10, 12])
Key secondary outcomes *Secondary outcomes
[1]Nasal discharge eosinophils (Week 0, 12)
[2]Blood IgE (Week 0, 12)
[3]Japanese edition of Profile of Mood States (2nd edition) (Week 0, 4, 8, 12)

*Safety evaluation
[1]Hematologic test (Week 0, 4, 8, 12)
[2]Blood biochemical test (Week 0, 4, 8, 12)
[3]Urine analysis (Week 0, 4, 8, 12)
[4]Blood pressure, pulsation (Week 0, 4, 8, 12)
[5]Weight, body fat percentage, BMI (Week 0, 4, 8, 12)
[6]Doctor's questions (Week 0, 4, 8, 12)

*Other indexes
[1]Questionnaire for allergic rhinitis (Week 0)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

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 Oral ingestion of the test food (6 tablets once a day for 12 weeks)
Interventions/Control_2 Oral ingestion of the placebo food (6 tablets once a day for 12 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]Japanese males and females aged 20-65 years.
[2]Individuals who are healthy and are not suffered from a chronic malady.
[3]Individuals with allergic rhinitis-symptoms.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals whose grade for the severity of allergic rhinitis is "severe" or "most severe".
[2]Individuals who visit a hospital or use a drug to treat perennial allergic rhinitis or pollinosis (except using nose drops and eye drops of category-3 OTC).
[3]Individuals using medical products.
[4]Individuals who are a patient of or have a history of bronchial disease.
[5]Individuals who are patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[6]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[7]Individuals who are sensitive to a test food, other foods, and medical products.
[8]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease.
[9]Individuals who are a patient or have a history of or endocrine disease.
[10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[11]Individuals who had an experience of side effects on blood sampling such as bad feeling or poor physical condition.
[12]Individuals who ingest food for specified health uses or foods with Function Claims (except individuals who can stop ingesting these food before an informed consent).
[13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[14]Individuals whose life style will change during the test period.
[15]Individuals who are or are possibly, or are lactating.
[16]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[17]Individuals who are or whose family is engaged in healthy or functional foods.
[18]Individuals judged inappropriate for the study by the principal.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Sugimoto
Organization Otsubokai Medical Corporation Tohto Bunkyo Hospital
Division name Head
Zip code
Address 3-5-7 Yushima Bunkyo-ku Tokyo 113-0034, JAPAN
TEL 03-3831-2181
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd
Division name Administrative Department of Clinical Trials
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization HIGASHIMARU SHOYU 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
2017 Year 09 Month 12 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 08 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 13 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
2017 Year 09 Month 11 Day
Last modified on
2017 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033198

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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