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

Chonbuk National University

Status

Completed

Conditions

Dry Eye Syndromes

Treatments

Dietary Supplement: Zanthoxylum Schinifolium Seed Oil(4g/day)

Dietary Supplement: Soy Bean Oil;placebo(4g/day)

Study type

Interventional

Funder types

Other

Identifiers

NCT02802150

CTCF2_2014_SC

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts 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