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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00739713
Date of registration: 21/08/2008
Prospective Registration: Yes
Primary sponsor: University of Turku
Public title: Effects of Sea Buckthorn Oil on Dry Eye DESB
Scientific title: Effects of Sea Buckthorn Oil on Dry Eye
Date of first enrolment: September 2008
Target sample size: 100
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00739713
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Finland
Contacts
Name:     Heikki P Kallio, Professor
Address: 
Telephone:
Email:
Affiliation:  University of Turku
Key inclusion & exclusion criteria

Inclusion Criteria:

- Dry eye symptoms

Exclusion Criteria:

- Severe illness

- Anticholinergic drugs

- Smoking



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Dry Eye Syndromes
Intervention(s)
Dietary Supplement: Placebo comparison
Dietary Supplement: Sea buckthorn (Hippophaƫ rhamnoides) oil
Primary Outcome(s)
Symptom severity: symptom questionnaires and clinical dry eye tests [Time Frame: 3 months intervention + 1 month after the intervention]
Secondary Outcome(s)
Tear film lipid profile, tear cytokines, inflammation mediators in blood [Time Frame: 3 months intervention + 1 month after the intervention]
Secondary ID(s)
DESB
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Turku University Hospital
Finnsusp Ltd.
Valioravinto Ltd
Aromtech Ltd.
Shiny Horse Ltd
The Finnish Funding Agency for Technology and Innovation (TEKES)
Turku Municipal Health Department/evo-funding
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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