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This study was conducted to investigate the effects of daily supplementation of Hydrolysed Red Ginseng Extract extract on dry eye.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrolysed Red Ginseng Extract | Experimental | 10 ml/day, 2.4g/day for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolysed Red Ginseng Extract | Dietary Supplement | 10 ml/day, 2.4g/day for 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In Cheon You, M.D., Ph.D. | Contact | +82-63-250-258 | you2ic@jbnu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| In Cheon You, M.D., Ph.D. | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | 54907 | South Korea |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo | Dietary Supplement | Placebo for 12 weeks |
|
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.
| 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 |