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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802150
• Other study ID #: CTCF2_2014_SC
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: June 13, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Dietary Supplement:
• Zanthoxylum Schinifolium Seed Oil(4g/day)
parallel design
• Soy Bean Oil;placebo(4g/day)
parallel design

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods	Jeonju	Jeollabuk-do
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from fatty acid composition of erythrocyte membrane	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.	baseline, 10 weeks	Yes
Primary	change from Schirmer test(mm)	Measures to assess differences baseline and after the 5-week and 10-week intervention period	baseline, 5weeks, 10 weeks	Yes
Primary	change from tear break-up time(seconds)	Measures to assess differences baseline and after the 5-week and 10-week	baseline, 5weeks, 10 weeks	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	change from interleukin-13(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from interferon-gamma(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from interleukin-1ß(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from interleukin-17(pg/mL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from malondialdehyde(nU/L)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from low-density lipoprotein(pmol/mg)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from total cholesterol(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from triglyceride(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from high-density lipoprotein cholesterol(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes
Secondary	change from low-density lipoprotein cholesterol(mg/dL)	Measures to assess differences baseline and after the 10-weeks	baseline, 10 weeks	Yes