Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

NCT ID: NCT03992287

Last Updated: 2019-12-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-07-31

Brief Summary

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This study was conducted to investigate the effects of daily supplementation of Hydrolysed Red Ginseng Extract extract on dry eye.

Detailed Description

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This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 46 subjects were randomly divided into Hydrolysed Red Ginseng extract 10ml or placebo group. The investigators measured Ocular Surface Disease Index, tear break-up time, Visual analog scale, Schirmer's test, meibomian gland test and Fluorescein staining.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hydrolysed Red Ginseng Extract

10 ml/day, 2.4g/day for 12 weeks

Group Type EXPERIMENTAL

Hydrolysed Red Ginseng Extract

Intervention Type DIETARY_SUPPLEMENT

10 ml/day, 2.4g/day for 12 weeks

Placebo

Placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for 12 weeks

Interventions

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Hydrolysed Red Ginseng Extract

10 ml/day, 2.4g/day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adult men and women over 19years
* 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 a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* 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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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You, In Cheon

Professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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In Cheon You, M.D., Ph.D.

Role: CONTACT

+82-63-250-258

Facility Contacts

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In cheon You, M.D., Ph.D.

Role: primary

+82-63-250-2581

Other Identifiers

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GH-DE-HR

Identifier Type: -

Identifier Source: org_study_id

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