UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043224 |
|---|---|
| Receipt number | R000049329 |
| Scientific Title | Study to evaluate the effect of continuous intake of test food on eye/nose symptoms -- Double-blind parallel-group comparative study -- |
| Date of disclosure of the study information | 2022/03/05 |
| Last modified on | 2024/05/17 12:28:45 |
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Basic information
Public title
Study to evaluate the effect of continuous intake of test food on eye/nose symptoms
-- Double-blind parallel-group comparative study --
Acronym
Study to evaluate the effect of continuous intake of test food on eye/nose symptoms
Scientific Title
Study to evaluate the effect of continuous intake of test food on eye/nose symptoms
-- Double-blind parallel-group comparative study --
Scientific Title:Acronym
Study to evaluate the effect of continuous intake of test food on eye/nose symptoms
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy, dose-dependently, and safety for eye/nose discomfort by ingesting test food for 4 weeks on healthy Japanese men and women aged between 20 and 65 years who are aware of eye and nose discomfort (sneezing, runny nose, stuffy nose, itchy eyes, etc.) in daily life.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japan Allergic Rhinitis Standard QOL Questionnaire (JRQLQ No1)
Key secondary outcomes
Japan Allergic Rhinitis Standard QOL Questionnaire (JRQLQ No1) overall score
Nose / Eye Symptom Questionnaire
Intranasal evaluation
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 1 packet of test food (low dose)daily with water before breakfast
Interventions/Control_2
Take 1 packet of test food (high dose)daily with water before breakfast
Interventions/Control_3
Take 1 packet of placebo daily with water before breakfast
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. Age between 20 and 65 years at the time of informed consent.
2. Japanese male or female
3. having symptoms of discomfort such as itchy eyes, runny nose, and stuffy nose due to dust, house dust, pollen, etc., but healthy and having no chronic physical illness
4. not having allergic drugs before and during the test (for healthy case), or taking allergic drugs occasionally before and during the test (not regularly)(for mild case)
5. BMI of less than 30 kg/m2
6. Not smoker (not electronic cigarette smoker)
7. Those who are able to input electronic diary with smartphone / PC.
8. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria
1. severe or most severe classification of allergic rhinitis symptoms
2. acute rhinitis, sinusitis, nasal polyps, hypertrophic rhinitis, nasal septum deviation
3. bronchial asthma
4. severe liver, heart, kidney, respiratory, endocrine and metabolic diseases
5. current or history of specific desensitization therapy
6. receiving some kind of drug for treatment
7. current or history of drug allergies or food allergies
8. history of discomfort or problems with physical symptoms after eating citrus fruits
9. consumption of food for specified health use or foods with functional claims
10. pregnant or lactating, or willing to be pregnant during the trial
11. experience of feeling sick due to blood collection, or told that blood vessels are thin at the time of blood collection
12. participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate
13. possible changes of their lifestyle, such as long trip, etc. during the study
14. alcohol consumption of >60g equivalent
15. irregular diet, shift worker, night shift, irregular life rhythm
16. judged by the investigator to be unsuitable for participating in this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Seisho |
| Middle name | |
| Last name | Azuma |
Organization
Jabara Laboratory Co., Ltd.
Division name
CEO
Zip code
640-8425
Address
4-7-18 Matsue-kita Wakayama city Wakayama
TEL
073-452-8188
jabara.labo@maia.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Seisho |
| Middle name | |
| Last name | Azuma |
Organization
Jabara Laboratory Co., Ltd.
Division name
CEO
Zip code
640-8425
Address
4-7-18 Matsue-kita Wakayama city Wakayama
TEL
073-452-8188
Homepage URL
jabara.labo@maia.eonet.ne.jp
Sponsor or person
Institute
Jabara Laboratory Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Jabara Laboratory Co., Ltd.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-3207-8161
jimukyoku@imeqrd.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | 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
90
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
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049329
