Dry EyeNCT03992287
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye
A study testing Hydrolysed Red Ginseng Extract in people with Dry Eye, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of Hydrolysed Red Ginseng Extract extract on dry eye. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Hydrolysed Red Ginseng Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
In cheon You, M.D., Ph.D., +82-63-250-2581, you2ic@jbnu.ac.kr
About this study
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
This study was conducted to investigate the effects of daily supplementation of Hydrolysed Red Ginseng Extract extract on dry eye.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Hydrolysed Red Ginseng Extract, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysed Red Ginseng ExtractDietary supplement
10 ml/day, 2.4g/day for 12 weeks
PlaceboDietary supplement
Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hydrolysed Red Ginseng Extract | Experimental | 10 ml/day, 2.4g/day for 12 weeks Receives: Dietary Supplement: Hydrolysed Red Ginseng Extract |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Mar 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You, In Cheon, Chonbuk National University Hospital
- Investigators
- In Cheon You, M.D., Ph.D., Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992287
- Sponsor's protocol ID
- GH-DE-HR
- Status last verified
- Nov 2019
- First submitted
- 18 Jun 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03992287
- Acronym / sponsor ID
- GH-DE-HR
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolysed Red Ginseng Extract | Experimental | Dietary Supplement: Hydrolysed Red Ginseng Extract10 ml/day, 2.4g/day for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolysed Red Ginseng Extract10 ml/day, 2.4g/day for 12 weeks | Dietary supplement | Hydrolysed Red Ginseng Extract |
| PlaceboPlacebo for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Changes of Ocular Surface Disease Index
Time frame: 12 weeks
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
Time frame: 12 weeks
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.
4 secondary outcomes
Changes of Visual analog scale
Time frame: 12 weeks
Changes of Schirmer's test
Time frame: 12 weeks
Changes of meibomian gland test
Time frame: 12 weeks
Changes of Fluorescein staining
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Cheon You, M.D., Ph.D. principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolysed Red Ginseng Extract in people with Dry Eye, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In Cheon You, M.D., Ph.D. (+82-63-250-258, you2ic@jbnu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Ocular Surface Disease Index (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.