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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

August 21, 2008
June 24, 2010
September 2008
March 2009   (final data collection date for primary outcome measure)
Symptom severity: symptom questionnaires and clinical dry eye tests [ Time Frame: 3 months intervention + 1 month after the intervention ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00739713 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Effects of Sea Buckthorn Oil on Dry Eye
Effects of Sea Buckthorn Oil on Dry Eye

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye Syndromes
  • Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil
    Dosage 2 g/d, frequency twice/d, duration 3 months
  • Dietary Supplement: Placebo comparison
    Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months
  • Experimental: SB
    Sea buckthorn oil group
    Intervention: Dietary Supplement: Sea buckthorn (Hippophaë rhamnoides) oil
  • Placebo Comparator: PL
    Placebo group
    Intervention: Dietary Supplement: Placebo comparison

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dry eye symptoms

Exclusion Criteria:

  • Severe illness
  • Anticholinergic drugs
  • Smoking
Both
20 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00739713
DESB
No
Matti Viitanen/ Professor, University of Turku
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)
Study Director: Heikki P Kallio, Professor University of Turku
University of Turku
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP