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Main
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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. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201012265467N1 |
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Date of registration:
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2012-04-03 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Impact of Omega-3 on Dry Eye
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Scientific title:
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The Impact of Omega-3 Fatty Acids Supplements on Dry Eye |
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Date of first enrolment:
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2012-04-20 |
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Target sample size:
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64 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/5868 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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N/A
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Countries of recruitment
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Albania
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr. Haleh Kangari
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Address:
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College of Rehabilitation, Corner of Bakhshifard Street, Damavand Ave. , Emam Hossein Square
1616913111
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 7756 1723 |
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Email:
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halehkangari@gmail.com |
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Affiliation:
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Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation |
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Name:
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Dr. Haleh Kangari
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Address:
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College of Rehabilitation, Corner of Bakhshifard Street, Damavand Ave., Emam Hossein Square
1616013111
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 7756 1723 |
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Email:
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halehkangari@gmail.com |
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Affiliation:
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Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation, Optometry Department |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion Criteria: Subjects with Tear Break up time of less than 10 seconds
Exclusion Criteria: The subjects with blood coagulation problems and those who take blood thinning medications such as warfarin or Coumadin, subject with the history of stomach ulcer, hemorrhage, or surgery in the past three months, history of allergies to fish oil or gelatinous capsules.
Exclusion criteria:
Age minimum:
40 years
Age maximum:
65 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dry eye.
other disorders of lacrimal gland
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other disorders of lacrimal gland
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Intervention(s)
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Intervention 1: Omega-3 Capsule b.i.d. for one month. Intervention 2: Placebo gelatinous capsule b.i.d for one month.
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Placebo gelatinous capsule b.i.d for one month
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Omega-3 Capsule b.i.d. for one month
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Treatment - Drugs
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Placebo
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Primary Outcome(s)
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Foreign body sensation, photophobia, blur vision, Burning. Timepoint: Before and after intervention. Method of measurement: Filling OSDI questionnaire.
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Tear Break Up time. Timepoint: Before and after one month intervention. Method of measurement: The time that takes for the first dry spot to appear following blinking after fluorescin instillation.
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Tear secretion. Timepoint: Before and after intervention. Method of measurement: Schirmer test- Wetting of the filter paper after 5 minutes.
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Source(s) of Monetary Support
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Shahid Beheshti University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
?Shahid Beheshti University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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