Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

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

Study Overview

• Status: Unknown
• Conditions: Dry Eye
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Hydrolysed Red Ginseng Extract

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.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In Cheon You, M.D., Ph.D.; Phone Number: +82-63-250-258; Email: you2ic@jbnu.ac.kr

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Recruiting
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital
      • Contact: In cheon You, M.D., Ph.D.; Phone Number: +82-63-250-2581; Email: you2ic@jbnu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo for 12 weeks	Dietary supplement: Placebo; Placebo for 12 weeks
Experimental: Hydrolysed Red Ginseng Extract; 10 ml/day, 2.4g/day for 12 weeks	Dietary supplement: Hydrolysed Red Ginseng Extract; 10 ml/day, 2.4g/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	12 weeks
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	12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Investigators: Principal Investigator: In Cheon You, M.D., Ph.D., Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): March 30, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: GH-DE-HR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No