Effects of Sea Buckthorn Oil on Dry Eye (DESB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Turku.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Turku Municipal Health Department/evo-funding
Turku University Hospital
Finnsusp Ltd.
Aromtech Ltd.
Shiny Horse Ltd
Valioravinto Ltd
The Finnish Funding Agency for Technology and Innovation (TEKES)
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00739713
First received: August 21, 2008
Last updated: June 24, 2010
Last verified: February 2009
  Purpose

The objective is to study the effect of sea buckthorn oil on dry eye.


Condition Intervention
Dry Eye Syndromes
Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil
Dietary Supplement: Placebo comparison

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Sea Buckthorn Oil on Dry Eye

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Symptom severity: symptom questionnaires and clinical dry eye tests [ Time Frame: 3 months intervention + 1 month after the intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tear film lipid profile, tear cytokines, inflammation mediators in blood [ Time Frame: 3 months intervention + 1 month after the intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: September 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB
Sea buckthorn oil group
Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil
Dosage 2 g/d, frequency twice/d, duration 3 months
Placebo Comparator: PL
Placebo group
Dietary Supplement: Placebo comparison
Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months

Detailed Description:

The objective is to study whether regular consumption of sea buckthorn berry oil can relieve the symptoms of dry eye syndrome. The study design is a parallel randomized double-blind placebo controlled trial. The participants daily consume sea buckthorn or placebo oil for 3 months. The dry eye symptoms will be monitored during the study using a validated questionnaire. In addition clinical dry eye tests are made by an ophthalmologist three time during the study. Samples will be taken for tear film lipid and cytokine analyses. Blood samples for the analyses of inflammatory markers are also obtained. The cytokine and other inflammation marker analyses are optional. The symptoms will be monitored and clinical tests made also 4 weeks after the participants have stopped consuming the study oils.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Dry eye symptoms

Exclusion Criteria:

  • Severe illness
  • Anticholinergic drugs
  • Smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739713

Locations
Finland
University of Turku
Turku, Finland, 20014
Sponsors and Collaborators
University of Turku
Turku Municipal Health Department/evo-funding
Turku University Hospital
Finnsusp Ltd.
Aromtech Ltd.
Shiny Horse Ltd
Valioravinto Ltd
The Finnish Funding Agency for Technology and Innovation (TEKES)
Investigators
Study Director: Heikki P Kallio, Professor University of Turku
  More Information

Publications:
Responsible Party: Matti Viitanen/ Professor, University of Turku
ClinicalTrials.gov Identifier: NCT00739713     History of Changes
Other Study ID Numbers: DESB
Study First Received: August 21, 2008
Last Updated: June 24, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by University of Turku:
dry eye
sea buckthorn
Hippophaë

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on July 23, 2014