NCT02802150.

Trial name or title	The effect of oral Zanthoxylum Schinifolium seed oil in individuals with dry eye disease
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 20 participants (planned) Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: South Korea Age (mean ± SD, range): 20 to 70 years (planned) Gender: both (planned) 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 Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: Zanthoxylum Schinifolium Seed Oil(4g/day) Intervention #2 (control): placebo/soy bean oil(4g/day) Length of follow‐up: 10 weeks Notes: none
Outcomes	Primary outcome(s): Schirmer test; TBUT; corneal staining; OSDI Secondary outcome(s): interleukin‐13; interferon‐gamma; interleukin‐1β; interleukin‐17; malondialdehyde; low‐density lipoprotein; total cholesterol; triglyceride; high‐density lipoprotein cholesterol; low‐density lipoprotein cholesterol Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, 5 weeks and 10 weeks Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	February 2015
Contact information	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital, Jeonju, Jeollabuk‐do, Korea, Republic of, 560‐822
Notes	Recruitment status: completed Actual completion date: February 2016 Last update posted: June 16, 2016