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

Not Applicable

Completed

• Conditions: Dry Eye Syndromes

• Registration Number: NCT02802150
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-07
• Study Completion: 2016-02
• Study First Submitted: 2016-02-17
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-13
• Last Update Submitted: 2016-06-13
• Study First Posted: 2016-06-16
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of

Clinical Trial Center for Functional Foods; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of