Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

Chonbuk National University

Status: Unknown

Conditions: Dry Eye

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Hydrolysed Red Ginseng Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT03992287

GH-DE-HR

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Hydrolysed Red Ginseng Extract

Experimental group

Description:

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

Treatment:

Dietary Supplement: Hydrolysed Red Ginseng Extract

Placebo

Placebo Comparator group

Description:

Placebo for 12 weeks

Treatment:

Dietary Supplement: Placebo