Protocol summary
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Study aim
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1.Determination of the effect of camelina oil on schirmer test score
2.Determination of the effect of camelina oil
3.Determination of the effect of camelina oil on the degree of dry eye
4.Determining the effect of camelina oil on staining cornea
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Design
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Clinical trial with community based and pragmatic control group, with parallel groups, three strains of blind, simple random
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Settings and conduct
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clinical trial,third blind, 60 patients referred to the Eye Clinic Hospital Bina of Tehran - Iran will be selected randomly. Correlation includes: patient, questioner, data analyzer
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
1. A moderate degree of dry eye
2. Ability to take oral capsules
3.Uploading consent form
4. Ability to re-examine for examination
5. People aged 18 to 65 years
exclusion criteria:
1.The eye syringe test is less than 5 mm.
2. Eye TBUT is less than 5 seconds.
3. Excessive staining cornea
4. There is at least the corneal ulcer in that eye
5.Pregnancy or breastfeeding
6. Any eye surgery over the past 6 months in the affected eye
7. Any significant changes in diet during the last month or during the course of treatment
8. Contact lens consumers
9. Cortico-steroid and topical ointment use last month
10.Use of any oral supplement
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Intervention groups
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The first group received 2 capsules of 5 grams of canola oil daily and the second group received 2 grams of 5 grams of paraffin oil per day
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Main outcome variables
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Schirmer test, Tear Break Up Time, The degree of dry eye of the questionnaire, the mean staining corne, lipid profiles
General information
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Reason for update
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It needs to be updated due to changes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180806040722N1
Registration date:
2019-04-22, 1398/02/02
Registration timing:
registered_while_recruiting
Last update:
2022-05-09, 1401/02/19
Update count:
1
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Registration date
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2019-04-22, 1398/02/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-01, 1397/06/10
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Expected recruitment end date
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2019-12-01, 1398/09/10
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Actual recruitment start date
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2018-09-01, 1397/06/10
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Actual recruitment end date
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2019-12-01, 1398/09/10
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Trial completion date
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2019-12-01, 1398/09/10
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Scientific title
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Effect of complementary supplementation Camelina Oil on the improvement of dry eye disease in patients with dry eye
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Public title
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Effect of complementary supplementation Camelina Oil on the improvement of dry eye disease in patients with dry eye
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with moderate dry eye
Ability to take oral capsules
Fill in the consent form
Ability to visit for examination
Exclusion criteria:
Eye shirmer test less than 5 mm
TBUT eyes less than 5 seconds
Excessive corneal opacification
The presence of corneal ulcer at least in that eye
Pregnancy or breastfeeding
Corticosteroid use or systemic anti-inflammatory treatment simultaneously
Taking any oral supplement
A clear change in diet during the last month or during treatment
Any eye surgery over the past 6 months in the affected eye
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
Actual sample size reached:
47
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization method, unit will be used individually and random numbers will be used
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Participants have a blinded role after informed consent, clinical care and outcome assessment
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-27, 1397/11/07
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Ethics committee reference number
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IR.TBZMED.REC.1397.890
Health conditions studied
1
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Description of health condition studied
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moderate dry eye
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ICD-10 code
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H04.1
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ICD-10 code description
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Other disorders of lacrimal gland Dacryops Dry eye syndrome
Primary outcomes
1
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Description
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schirmer test
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Timepoint
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5-10 mm
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Method of measurement
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Paper tape of schirmer
2
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Description
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tear break up time
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Timepoint
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5-10 second
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Method of measurement
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Coloring with fluorescein
Intervention groups
1
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Description
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Control group1: Capsule containing Comelina Oil, 0.5 grams, twice a day, 3 months, accompanied by breakfast and lunch, Vegeterian Company Barich Esanse
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Category
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Treatment - Drugs
2
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Description
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Control group2: Capsule containing paraffin oil, 0.5 grams, twice a day, 3 months, accompanied by breakfast and lunch ,Vegeterian Company Barich Esanse
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iranian academic center for education culture and research
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Proportion provided by this source
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80
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Public or private sector
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Private
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Domestic or foreign origin
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Foreign
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Category of foreign source of funding
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UN agencies and international organizations
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable