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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
20
parallel design
parallel design
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Clinical Trial Center for Functional Foods
Jeonju, Jeollabuk-do, South Korea
change from Schirmer test(mm)
Measures to assess differences baseline and after the 5-week and 10-week intervention period
Time frame: baseline, 5weeks, 10 weeks
change from tear break-up time(seconds)
Measures to assess differences baseline and after the 5-week and 10-week
Time frame: 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
Time frame: 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
Time frame: baseline, 5weeks, 10 weeks
change from interleukin-13(pg/mL)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from interferon-gamma(pg/mL)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from interleukin-1β(pg/mL)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from interleukin-17(pg/mL)
Measures to assess differences baseline and after the 10-weeks
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Time frame: baseline, 10 weeks
change from malondialdehyde(nU/L)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from low-density lipoprotein(pmol/mg)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from total cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from triglyceride(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from high-density lipoprotein cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks
change from low-density lipoprotein cholesterol(mg/dL)
Measures to assess differences baseline and after the 10-weeks
Time frame: baseline, 10 weeks