UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053239 |
|---|---|
| Receipt number | R000060682 |
| Scientific Title | Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy in healthy or mild adults -Randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2024/01/19 09:58:31 |
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Basic information
Public title
Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy in healthy or mild adults
-Randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy
Scientific Title
Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy in healthy or mild adults
-Randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Efficacy evaluation of a food ingredient to ocular and nasal symptoms of allergy
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of oral administration of a food ingredient on ocular and nasal symptoms of allergy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Efficacy>
The discomfort of eyes and nose in the daily life
Key secondary outcomes
<Efficacy>
Evaluation of allergic rhinitis
Specific measurement of blood
<Safety>
Blood pressure, pulse, body weight,
body fat percentage, body mass index, hematology test, biochemical test, urinalysis, assessment of adverse events by a medical doctor.
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intakes of test tablets for 12 weeks
Interventions/Control_2
Intakes of placebo tablets 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.Male and Female aged from 20 to 64 years, when giving the informed consent.
2.Healthy individuals not having any chronic diseases.
3.Individuals with allergic reaction of eyes and nose in early spring.
4.Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
5.Individuals who can accomplish their tasks in the study at the appointed date
6.Individuals who are judged suitable for this study by the investigator.
Key exclusion criteria
Individuals
1.who have some diseases with drug therapy.
2.who sometimes or regularly use oral antiallergic drugs or will use during the test period.
3.who have history of intranasal laser therapy or sublingual immunotherapy to reduce allergic symptoms.
4.who are a patient of or have a history of asthma.
5.who are a patient of or have a history of atopic dermatitis or chronic urticaria.
6.who are a patient or have a history of mental disease, psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
7.who consecutively receive drugs for treatment of disease in the last 1 month.
8.who could have severe allergy to foods or drugs.
9.who have severe disease histories in liver, kidney, heart, lung, blood or the other tissues.
10.who are a patient or have a history of endocrine disease.
11.whose BMI is over 30 kg/m2
12.who have donated over 200 mL of blood in the last 1 month or 400 mL of blood in the last 3 months.
13.who cannot stop to ingest intestinal drugs or supplements during the test period.
14.who had a habit to ingest health-promoting foods, health foods, or supplements containing similar composition with a test food or will ingest those foods during the test period.
15.who generally intake alcohol drinks over 60g/day as the amount of pure alcohol.
16.who could change their location and their life style during the study, e.g. business trip or traveling for a long time.
17.who are pregnant, breastfeeding, or planning to be pregnant.
18.who participated in other clinical trials in the last 3 months.
19.who and whose family work for a company manufacturing or selling healthy foods, functional foods.
20.who refuse to disclose their biological sex.
21.who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Nozawa |
Organization
Kirin Holdings Company, Limited
Division name
Institute of Health Sciences
Zip code
251-8555
Address
Shonan-health-innovation-park 26-1 Muraoka-Higashi 2-chome Fujisawa Kanagawa Japan
TEL
080-2289-3085
h-nozawa@kirin.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo, 110-0015 JAPAN
TEL
03-6801-8480(+81-3-6801-8480)
Homepage URL
r.shimizu@tes-h.c.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kirin Group
Address
4-10-2, Nakano, Nakano-ku, Tokyo
Tel
03-6837-4128
02976_Ni@kirin.co.jp
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
えのあさがおクリニック (東京都)/ Ueno-Asagao Clinic
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060682
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| Research case data specifications | |
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| Registered date | File name |
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