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Completed

NCT Number: NCT02802150

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

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods, Jeonju, Jeollabuk-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zanthoxylum Schinifolium Seed Oil(4g/day)

Dietary Supplement

parallel design

Soy Bean Oil;placebo(4g/day)

Dietary Supplement

parallel design

Primary outcomes

  1. change from Schirmer test(mm)

    Time frame: baseline, 5weeks, 10 weeks

    Measures to assess differences baseline and after the 5-week and 10-week intervention period

  2. change from tear break-up time(seconds)

    Time frame: baseline, 5weeks, 10 weeks

    Measures to assess differences baseline and after the 5-week and 10-week

  3. change from corneal staining(0 to 5 grade)

    Time frame: baseline, 5weeks, 10 weeks

    Measures to assess differences baseline and after the 5-week and 10-week

  4. change from ocular surface disease index(0 to 100 score)

    Time frame: baseline, 5weeks, 10 weeks

    Measures to assess differences baseline and after the 5-weeks and 10-weeks

Secondary outcomes

  1. change from interleukin-13(pg/mL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  2. change from interferon-gamma(pg/mL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  3. change from interleukin-1β(pg/mL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  4. change from interleukin-17(pg/mL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  5. change from malondialdehyde(nU/L)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  6. change from low-density lipoprotein(pmol/mg)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  7. change from total cholesterol(mg/dL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  8. change from triglyceride(mg/dL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  9. change from high-density lipoprotein cholesterol(mg/dL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

  10. change from low-density lipoprotein cholesterol(mg/dL)

    Time frame: baseline, 10 weeks

    Measures to assess differences baseline and after the 10-weeks

Other outcomes

  1. change from fatty acid composition of erythrocyte membrane

    Time frame: baseline, 10 weeks

    Fatty acid composition(%)

    • Palmitic (C16:0)
    • Palmitoleic (C16:1)
    • Stearic (C18:0)
    • Oleic (C18:1)
    • iso-Oleic (C18:1cis)
    • Linoleic (C18:2)
    • Linolenic (C18:3) --> Measures to assess differences baseline and after the 10-week intervention period.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 16, 2016
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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