NCT03992287

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

June 18, 2019

Last Update Submit

November 28, 2019

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Changes of Visual analog scale

    12 weeks

  • Changes of Schirmer's test

    12 weeks

  • Changes of meibomian gland test

    12 weeks

  • Changes of Fluorescein staining

    12 weeks

Study Arms (2)

Hydrolysed Red Ginseng Extract

EXPERIMENTAL

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

Dietary Supplement: Hydrolysed Red Ginseng Extract

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks

Dietary Supplement: Placebo

Interventions

Hydrolysed Red Ginseng ExtractDIETARY_SUPPLEMENT

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

Hydrolysed Red Ginseng Extract
PlaceboDIETARY_SUPPLEMENT

Placebo for 12 weeks

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • In Cheon You, M.D., Ph.D.

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

In Cheon You, M.D., Ph.D.

CONTACT

+82-63-250-258you2ic@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of ophthalmology

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

March 1, 2019

Primary Completion

March 30, 2020

Study Completion

July 31, 2020

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

KR(1)