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The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zanthoxylum Schinifolium Seed Oil(4g/day)
Soy Bean Oil;placebo(4g/day)
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Syndromes focused on measuring Zanthoxylum schinifolium seed Oil, soy bean oil, omega-3 fatty acid, dry eye disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • men and women
  • 20 to 70 years with dry eye disease
  • low tear break-up time (TBUT) (<10 seconds) or low Schirmer score (with application of local anesthetic) (<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening.
  • blood level of triglyceride higher than 150 mg/dL or HDL-cholesterol less than 40 and 50 mg/dL for men and women, respectively.

Exclusion Criteria:

  • under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin)
  • hypolipidemic medication within 3 months of study entry
  • history of chronic disease
  • any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study
  • allergic or hypersensitive to any of the ingredients in the test products.
  • women who were pregnant or breast feeding
  • a history of alcoholism or drug abuse or medical or psychological conditions

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
  • Clinical Trial Center for Functional Foods

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zanthoxylum schinifolium seed Oil

soy bean oil

Arm Description

Zanthoxylum schinifolium seed Oil 100% (4g/day)

soy bean oil 99.9%, edible dyes 0.01% (4g/day)

Outcomes

Primary Outcome Measures

change from Schirmer test(mm)
Measures to assess differences baseline and after the 5-week and 10-week intervention period
change from tear break-up time(seconds)
Measures to assess differences baseline and after the 5-week and 10-week
change from corneal staining(0 to 5 grade)
Measures to assess differences baseline and after the 5-week and 10-week
change from ocular surface disease index(0 to 100 score)
Measures to assess differences baseline and after the 5-weeks and 10-weeks

Secondary Outcome Measures

change from interleukin-13(pg/mL)
Measures to assess differences baseline and after the 10-weeks
change from interferon-gamma(pg/mL)
Measures to assess differences baseline and after the 10-weeks
change from interleukin-1β(pg/mL)
Measures to assess differences baseline and after the 10-weeks
change from interleukin-17(pg/mL)
Measures to assess differences baseline and after the 10-weeks
change from malondialdehyde(nU/L)
Measures to assess differences baseline and after the 10-weeks
change from low-density lipoprotein(pmol/mg)
Measures to assess differences baseline and after the 10-weeks
change from total cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
change from triglyceride(mg/dL)
Measures to assess differences baseline and after the 10-weeks
change from high-density lipoprotein cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
change from low-density lipoprotein cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks

Full Information

First Posted
February 17, 2016
Last Updated
June 13, 2016
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02802150
Brief Title
The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral consumption of Zanthoxylum schinifolium seed Oil (ZSO) in patients with mild dry eye disease.
Detailed Description
In this double-blind, randomized and placebo-controlled trial, twenty participants experiencing dry eyes symptoms were recruited, and randomly assigned to consume 4 g/day of either ZSO or soy bean oil (SBO) as placebo for 10 weeks. All participants completed the study. Follow-ups of dry eye symptoms and objective signs, inflammatory and oxidative stress markers, and blood lipid analysis were performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Zanthoxylum schinifolium seed Oil, soy bean oil, omega-3 fatty acid, dry eye disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zanthoxylum schinifolium seed Oil
Arm Type
Active Comparator
Arm Description
Zanthoxylum schinifolium seed Oil 100% (4g/day)
Arm Title
soy bean oil
Arm Type
Placebo Comparator
Arm Description
soy bean oil 99.9%, edible dyes 0.01% (4g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Zanthoxylum Schinifolium Seed Oil(4g/day)
Intervention Description
parallel design
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy Bean Oil;placebo(4g/day)
Intervention Description
parallel design
Primary Outcome Measure Information:
Title
change from Schirmer test(mm)
Description
Measures to assess differences baseline and after the 5-week and 10-week intervention period
Time Frame
baseline, 5weeks, 10 weeks
Title
change from tear break-up time(seconds)
Description
Measures to assess differences baseline and after the 5-week and 10-week
Time Frame
baseline, 5weeks, 10 weeks
Title
change from corneal staining(0 to 5 grade)
Description
Measures to assess differences baseline and after the 5-week and 10-week
Time Frame
baseline, 5weeks, 10 weeks
Title
change from ocular surface disease index(0 to 100 score)
Description
Measures to assess differences baseline and after the 5-weeks and 10-weeks
Time Frame
baseline, 5weeks, 10 weeks
Secondary Outcome Measure Information:
Title
change from interleukin-13(pg/mL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from interferon-gamma(pg/mL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from interleukin-1β(pg/mL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from interleukin-17(pg/mL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from malondialdehyde(nU/L)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from low-density lipoprotein(pmol/mg)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from total cholesterol(mg/dL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from triglyceride(mg/dL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from high-density lipoprotein cholesterol(mg/dL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Title
change from low-density lipoprotein cholesterol(mg/dL)
Description
Measures to assess differences baseline and after the 10-weeks
Time Frame
baseline, 10 weeks
Other Pre-specified Outcome Measures:
Title
change from fatty acid composition of erythrocyte membrane
Description
Fatty acid composition(%) Palmitic (C16:0) Palmitoleic (C16:1) Stearic (C18:0) Oleic (C18:1) iso-Oleic (C18:1cis) Linoleic (C18:2) Linolenic (C18:3) --> Measures to assess differences baseline and after the 10-week intervention period.
Time Frame
baseline, 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: men and women 20 to 70 years with dry eye disease low tear break-up time (TBUT) (<10 seconds) or low Schirmer score (with application of local anesthetic) (<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening. blood level of triglyceride higher than 150 mg/dL or HDL-cholesterol less than 40 and 50 mg/dL for men and women, respectively. Exclusion Criteria: under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin) hypolipidemic medication within 3 months of study entry history of chronic disease any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study allergic or hypersensitive to any of the ingredients in the test products. women who were pregnant or breast feeding a history of alcoholism or drug abuse or medical or psychological conditions
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
Facility Name
Clinical Trial Center for Functional Foods
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Oral Zanthoxylum Schinifolium Seed Oil in Individuals With Dry Eye Disease

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