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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Zanthoxylum schinifolium seed Oil

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

Group Type ACTIVE_COMPARATOR

Zanthoxylum Schinifolium Seed Oil(4g/day)

Intervention Type DIETARY_SUPPLEMENT

parallel design

soy bean oil

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

Group Type PLACEBO_COMPARATOR

Soy Bean Oil;placebo(4g/day)

Intervention Type DIETARY_SUPPLEMENT

parallel design

Interventions

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Zanthoxylum Schinifolium Seed Oil(4g/day)

parallel design

Intervention Type DIETARY_SUPPLEMENT

Soy Bean Oil;placebo(4g/day)

parallel design

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes