Effects of Sea Buckthorn Oil on Dry Eye (DESB)

March 19, 2018 updated by: University of Turku
The objective is to study the effect of sea buckthorn oil on dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20014
        • University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dry eye symptoms

Exclusion Criteria:

  • Severe illness
  • Anticholinergic drugs
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom severity: symptom questionnaires and clinical dry eye tests
Time Frame: 3 months intervention + 1 month after the intervention
3 months intervention + 1 month after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Tear film lipid profile, tear cytokines, inflammation mediators in blood
Time Frame: 3 months intervention + 1 month after the intervention
3 months intervention + 1 month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Turku University Hospital
The Finnish Funding Agency for Technology and Innovation (TEKES)
Aromtech Ltd.
Finnsusp Ltd.
Turku Municipal Health Department/evo-funding
Shiny Horse Ltd
Valioravinto Ltd

Investigators

  • Study Director: Heikki P Kallio, Professor, University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DESB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Syndromes

Clinical Trials on Sea buckthorn (Hippophaë rhamnoides) oil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe