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

Study Overview
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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.

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

Intervention / Treatment
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* Dietary Supplement: Zanthoxylum Schinifolium Seed Oil(4g/day)
* Dietary Supplement: Soy Bean Oil;placebo(4g/day)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zanthoxylum schinifolium seed Oil<br>Zanthoxylum schinifolium seed Oil 100% (4g/day) | Dietary Supplement: Zanthoxylum Schinifolium Seed Oil(4g/day)<br>* parallel design<br>|
| Placebo Comparator: soy bean oil<br>soy bean oil 99.9%, edible dyes 0.01% (4g/day) | Dietary Supplement: Soy Bean Oil;placebo(4g/day)<br>* parallel design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Schirmer test(mm) | 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) | 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) | 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) | Measures to assess differences baseline and after the 5-weeks and 10-weeks | baseline, 5weeks, 10 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zanthoxylum schinifolium seed Oil, soy bean oil, omega-3 fatty acid, dry eye disease