UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045484 |
|---|---|
| Receipt number | R000051884 |
| Scientific Title | A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2022/01/13 10:36:44 |
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Basic information
Public title
A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Acronym
A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Scientific Title
A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Scientific Title:Acronym
A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the improvement effects on eye moisturization by oral intake of enzymatic decomposed rooster comb (INJUV(TM)) in human.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DEQS,Visual Analogue Scale,BUT(Tear film break-up time),Schirmer's test
Key secondary outcomes
Visual acuity examination, Intraocular pressure examination,Refraction inspection,Anti-aging QOL common questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test product (4 weeks)
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Japanese males and females aged 20-59 years
[2]Healthy individuals without chronic diseases, including eye and skin disorders
[3]Individuals who have dry eye like symptoms in their daily lives (tired eyes, rough eyes, eye dry feeling, discomfort in eyes, tingling in eyes, red eyes, difficulty in opening eyes in the morning, crumpled eyes, etc.)
[4]Individuals who works with VDT (Visual Display Terminals) for 5 days or more a week (in total 20 hours or more a week including video games, PC and mobile phone operation time)
[5]Individuals with corrected visual acuity of 1.0 or higher who are not wearing contact lenses or who can change to eyeglasses during the study period
[6]Individuals voluntarily to join the study with written informed consent
[7]Individuals who can visit study site and receive examinations on designated days
[8]Individuals judged appropriate to join this study by principal investigators
Key exclusion criteria
[1]Individuals receiving medical drugs for treatment of chronic diseases
[2]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication such as headache, menstrual pain, common cold, etc.
[3]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[5]Individuals with history of gastrointestinal disorders except for appendicitis
[6]Individuals who use artificial tears (eye drops) 6 times or more a day
[7]Individuals diagnosed with presbyopia or aware of presbyopia
[8]Individuals with eye disease, entropion of the eyelids, trichiasis
[9]Individuals with a definitive diagnosis of dry eye
[10]Individuals using eye drops to treat eye diseases
[11]Individuals with refractive error and not properly corrected
[12]Individuals undergoing LASIK surgery
[13]Individuals with severe astigmatism
[14]Individuals who are thought to have eye strain due to dysregulation such as neurosis
[15]Individuals with >=30.0kg/m2 BMI
[16]Individuals with drug or food allergies
[17]Individuals who have a habit of continuing to take functional foods, health foods, and supplements for the purpose of improving eye function, or who plan to take them during the study period, now and within the past 3 months
[18]Individuals who are currently or within the last 3 months taking health foods containing enzymatic decomposed rooster combs, hyaluronic acid, collagen, proteoglycans, elastin, or their precursors during the study period or individuals planning to take new those products
[19]Individuals with alcohol intake exceeding 60g/day
[20]Individuals who may significantly change their lifestyle during the study period
[21]Individuals who work at night
etc.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Tamura |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
Zip code
1100015
Address
6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL
03-6801-8400
Homepage URL
info@tes-h.co.jp
Sponsor or person
Institute
LAIMU Corporation
Institute
Department
Personal name
Funding Source
Organization
LAIMU Corporation
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
Society of Glycative Stress Research
Address
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.com
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
うえのあさがおクリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 15 | 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
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 05 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051884
