Clinical trial NCT03992287: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes of Ocular Surface Disease Index
timeFrame: 12 weeks
measure: Changes of tear break-up time
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of Visual analog scale
timeFrame: 12 weeks
measure: Changes of Schirmer's test
timeFrame: 12 weeks
measure: Changes of meibomian gland test
timeFrame: 12 weeks
measure: Changes of Fluorescein staining
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: In Cheon You, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: