search
Back to results

Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

Primary Purpose

Dry Eye

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hydrolysed Red Ginseng Extract
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Eye

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Trial Center for Functional Foods Chonbuk National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydrolysed Red Ginseng Extract

Placebo

Arm Description

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

Placebo for 12 weeks

Outcomes

Primary Outcome Measures

Changes of Ocular Surface Disease Index
A questionnaire which is Ocular Surface Disease Index consisted of 12 questions each of which included visual symptoms, visual work status, and environmental factors. The Ocular Surface Disease Index scores are ranged from 0 to 100, and the high score is the more severe the symptoms. The Ocular Surface Disease Index score is calculated as follows. : (Sum of all items answered × 25) / total number of questions answered
Changes of tear break-up time
The tear break-up time test measures the time in seconds. The time is from the last blinking to the point of tear layer defect or streak-like defect after blinking the eye with 1% of fluorescein. 10 seconds or more as normal, between 5 and 10 seconds as mild dry eye syndrome, and 5 seconds or less as severe dry eye syndrome.

Secondary Outcome Measures

Changes of Visual analog scale
The Visual Analog Scale(VAS) score is 0 point for no symptom, 10 points for the most severe symptom, and the patient is asked to mark the degree of subjective pain symptoms as an integer.
Changes of Schirmer's test
Schirmer's test determines whether the eye produces enough tears to keep it moist. This test is used when a person experiences very dry eyes or excessive watering of the eyes. It poses no risk to the subject. A negative (more than 10 mm of moisture on the filter paper in 5 minutes) test result is normal. Both eyes normally secrete the same amount of tears.
Changes of meibomian gland test
Meibomian gland test evaluate 8 Meibum of the upper middle eyelid or lower middle eyelid. The Meibum quality score and the Meibum expressibility score are evaluated as follows. Meibum quality score 0 = clear fluid = cloudy fluid = cloudy particulate fluid(with debris) = inspissated (opaque),like toothpaste Meibum expressibility score 0 = all glands expressible = three to four glands expressible = one to two glands expressible = no glands expressible
Changes of Fluorescein staining
Fluorescein staining was evaluated by staining with 1% fluorescein (1% sodium fluorescein 1 μL volume), and then assessed for damage after corneal and conjunctival staining. The degree of staining of the cornea is divided into 5 sections according to the NEI scale, and each section is judged as 0 ~ 3 scores. It is judgement the degree of severity from 0 to 15 scores per eye. The degree of conjunctival staining is divided into six sections per eye, and each section is scored 0 to 3 scores total 0 ~ 18 scores.

Full Information

First Posted
June 18, 2019
Last Updated
November 28, 2019
Sponsor
Chonbuk National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03992287
Brief Title
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye
Official Title
A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrolysed Red Ginseng Extract
Arm Type
Experimental
Arm Description
10 ml/day, 2.4g/day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydrolysed Red Ginseng Extract
Intervention Description
10 ml/day, 2.4g/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks
Primary Outcome Measure Information:
Title
Changes of Ocular Surface Disease Index
Description
A questionnaire which is Ocular Surface Disease Index consisted of 12 questions each of which included visual symptoms, visual work status, and environmental factors. The Ocular Surface Disease Index scores are ranged from 0 to 100, and the high score is the more severe the symptoms. The Ocular Surface Disease Index score is calculated as follows. : (Sum of all items answered × 25) / total number of questions answered
Time Frame
12 weeks
Title
Changes of tear break-up time
Description
The tear break-up time test measures the time in seconds. The time is from the last blinking to the point of tear layer defect or streak-like defect after blinking the eye with 1% of fluorescein. 10 seconds or more as normal, between 5 and 10 seconds as mild dry eye syndrome, and 5 seconds or less as severe dry eye syndrome.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes of Visual analog scale
Description
The Visual Analog Scale(VAS) score is 0 point for no symptom, 10 points for the most severe symptom, and the patient is asked to mark the degree of subjective pain symptoms as an integer.
Time Frame
12 weeks
Title
Changes of Schirmer's test
Description
Schirmer's test determines whether the eye produces enough tears to keep it moist. This test is used when a person experiences very dry eyes or excessive watering of the eyes. It poses no risk to the subject. A negative (more than 10 mm of moisture on the filter paper in 5 minutes) test result is normal. Both eyes normally secrete the same amount of tears.
Time Frame
12 weeks
Title
Changes of meibomian gland test
Description
Meibomian gland test evaluate 8 Meibum of the upper middle eyelid or lower middle eyelid. The Meibum quality score and the Meibum expressibility score are evaluated as follows. Meibum quality score 0 = clear fluid = cloudy fluid = cloudy particulate fluid(with debris) = inspissated (opaque),like toothpaste Meibum expressibility score 0 = all glands expressible = three to four glands expressible = one to two glands expressible = no glands expressible
Time Frame
12 weeks
Title
Changes of Fluorescein staining
Description
Fluorescein staining was evaluated by staining with 1% fluorescein (1% sodium fluorescein 1 μL volume), and then assessed for damage after corneal and conjunctival staining. The degree of staining of the cornea is divided into 5 sections according to the NEI scale, and each section is judged as 0 ~ 3 scores. It is judgement the degree of severity from 0 to 15 scores per eye. The degree of conjunctival staining is divided into six sections per eye, and each section is scored 0 to 3 scores total 0 ~ 18 scores.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
In Cheon You, M.D., Ph.D.
Phone
+82-63-250-258
Email
you2ic@jbnu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Cheon You, M.D., Ph.D.
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In cheon You, M.D., Ph.D.
Phone
+82-63-250-2581
Email
you2ic@jbnu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

We'll reach out to this number within 24 hrs