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

June 13, 2016 updated by: Soo-Wan Chae, Chonbuk National University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Zanthoxylum schinifolium seed Oil
Zanthoxylum schinifolium seed Oil 100% (4g/day)
Dietary supplement: Zanthoxylum Schinifolium Seed Oil(4g/day)
parallel design
Placebo Comparator: soy bean oil
soy bean oil 99.9%, edible dyes 0.01% (4g/day)
Dietary supplement: Soy Bean Oil;placebo(4g/day)
parallel design

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change from Schirmer test(mm)
Time Frame: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week intervention period
baseline, 5weeks, 10 weeks
change from tear break-up time(seconds)
Time Frame: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week
baseline, 5weeks, 10 weeks
change from corneal staining(0 to 5 grade)
Time Frame: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-week and 10-week
baseline, 5weeks, 10 weeks
change from ocular surface disease index(0 to 100 score)
Time Frame: baseline, 5weeks, 10 weeks
Measures to assess differences baseline and after the 5-weeks and 10-weeks
baseline, 5weeks, 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from interleukin-13(pg/mL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from interferon-gamma(pg/mL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from interleukin-1β(pg/mL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from interleukin-17(pg/mL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from malondialdehyde(nU/L)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from low-density lipoprotein(pmol/mg)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from total cholesterol(mg/dL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from triglyceride(mg/dL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from high-density lipoprotein cholesterol(mg/dL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks
change from low-density lipoprotein cholesterol(mg/dL)
Time Frame: baseline, 10 weeks
Measures to assess differences baseline and after the 10-weeks
baseline, 10 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from fatty acid composition of erythrocyte membrane
Time Frame: baseline, 10 weeks

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.
baseline, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTCF2_2014_SC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings