Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye
NCT ID: NCT03992287
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
46 participants
INTERVENTIONAL
2019-03-01
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Hydrolysed Red Ginseng Extract
10 ml/day, 2.4g/day for 12 weeks
Hydrolysed Red Ginseng Extract
10 ml/day, 2.4g/day for 12 weeks
Placebo
Placebo for 12 weeks
Placebo
Placebo for 12 weeks
Interventions
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Hydrolysed Red Ginseng Extract
10 ml/day, 2.4g/day for 12 weeks
Placebo
Placebo for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Ocular Surface Disease Index score is 13 scores and more at a screening
* Tear Break-Up Time is 10 seconds less or those who have positive in ocular staining test at a screening
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Exclusion Criteria
* Those who have clinically significant acute or chronic ophthalmologic, cardiovascular system, endocrine, immune, respiratory, liver biliary system, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Those who couldn't control diabetes at screening
* Those with acute eye infections or inflammation within 1 month before screening
* Those who have ophthalmic surgery within 3 months before screening
* Those who use contact lens 1 month before screening
* Those who take a medication or health function food that affects your promotion of dry eye within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by showing the following results
* Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breastfeeding
* Those who don't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in the study because of Laboratory test results, etc.
19 Years
ALL
Yes
Sponsors
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Chonbuk National University Hospital
OTHER
Responsible Party
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You, In Cheon
Professor of ophthalmology
Principal Investigators
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In Cheon You, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Locations
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Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GH-DE-HR
Identifier Type: -
Identifier Source: org_study_id
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