NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000045484

Registered date:15/09/2021

A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedN/A (healthy adults)
Date of first enrollment2021/09/21
Target sample size12
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Oral intake of the test product (4 weeks)

Outcome(s)

Primary OutcomeDEQS,Visual Analogue Scale,BUT(Tear film break-up time),Schirmer's test
Secondary OutcomeVisual acuity examination, Intraocular pressure examination,Refraction inspection,Anti-aging QOL common questionnaire

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum60years-old
GenderMale and Female
Include criteria
Exclude 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.

Related Information

Contact

public contact
Name Toshiyasu Tamura
Address 6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo Japan 1100015
Telephone 03-6801-8400
E-mail info@tes-h.co.jp
Affiliation TES Holdings Co., Ltd. Department of Clinical Trial
scientific contact
Name Yoshikazu Yonei
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto Japan
Telephone 0774-65-6394
E-mail yyonei@mail.doshisha.ac.jp
Affiliation Faculty of Life and Medical Sciences,Doshisha University Anti-Aging Medical Research Center