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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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History
# Registration date Revision Id
2 2021-12-13, 1400/09/22 225417
1 2019-04-22, 1398/02/02 87331
Changes made to previous revision

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  • General information

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    3
    60
    50
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    47
    No
    No
    2640-02-11, 2018/11/22
    2018-09-01, 1397/06/10
    2640-06-12, 2019/03/22
    2019-12-01, 1398/09/10
    empty
    2018-09-01, 1397/06/10
    empty
    2019-12-01, 1398/09/10
    empty
    2019-12-01, 1398/09/10
    empty
    It needs to be updated due to changes
    empty
    به علت تغییراتی نیاز به بروزسانی هست

  • Intervention groups

    #1
    Control group1: Capsule containing Comelina Oil, 2 grams, twice a day, 3 months, accompanied by breakfast and lunch, Vegeterian Company Barich Esanse
    Control group1: Capsule containing Comelina Oil, 0.5 grams, twice a day, 3 months, accompanied by breakfast and lunch, Vegeterian Company Barich Esanse
    "گروه کنترل۱": ک‍‍پسول حاوی روغن کاملینا، دو گرم، دو بار در روز، ۳ ماه، همراه صبحانه و همراه نهار، شرکت گیاهی باریچ اسانس
    "گروه کنترل۱": ک‍‍پسول حاوی روغن کاملینا، نیم گرم، دو بار در روز، ۳ ماه، همراه صبحانه و همراه نهار، شرکت گیاهی باریچ اسانس
    #2
    Control group2: Capsule containing paraffin oil, two grams, twice a day, 3 months, accompanied by breakfast and lunch ,Vegeterian Company Barich Esanse
    Control group2: Capsule containing paraffin oil, 0.5 grams, twice a day, 3 months, accompanied by breakfast and lunch ,Vegeterian Company Barich Esanse
    "گروه کنترل2": ک‍‍پسول حاوی روغن پارافین خوراکی، دو گرم، دو بار در روز، ۳ ماه، همراه صبحانه و همراه نهار، شرکت گیاهی باریچ اسانس
    "گروه کنترل2": ک‍‍پسول حاوی روغن پارافین خوراکی، نیم گرم، دو بار در روز، ۳ ماه، همراه صبحانه و همراه نهار، شرکت گیاهی باریچ اسانس

  • Recruitment centers

    #1
    Name of recruitment center - English: Bina hospital
    Name of recruitment center - Persian: بیمارستان بینا
    Full name of responsible person - English: Khosro jadidi
    Full name of responsible person - Persian: خسرو جدیدی
    Street address - English: Opposite the Lightroom Business Complex,Resalat
    Street address - Persian: رسالت، روبروی دنیای نور
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 17788561
    Phone: +98 21 23535
    Fax:
    Email: Bina.Hospital@yahoo.com
    Web page address:
    Name of recruitment center - English: vision health research center
    Name of recruitment center - Persian: مرکز سلامت بینایی
    Full name of responsible person - English: Khosrow Jadidi
    Full name of responsible person - Persian: خسرو جدیدی
    Street address - English: Valiasr St., 2 Gandhi Alley, No. 8
    Street address - Persian: خیابان ولیعصر،کوچه 2 گاندی،پلاک 8
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 17788561
    Phone: +98 21 8819 6862
    Fax:
    Email: kh.jadidi@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ali Barzegar
    Full name of responsible person - Persian: علی برزگر
    Street address - English: Faculty of Nutrition Sciences, Tabriz University of Medical Sciences,
    Street address - Persian: تبریز گلگشت دانشگاه علوم ‍تبریز دانشکده تغذیه
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 178651
    Phone: +98 21 23535
    Fax:
    Email: Alibarzegar@hotmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: khosrow jadidi
    Full name of responsible person - Persian: خسروجدیدی
    Street address - English: Valiasr St., 2 Gandhi Alley, No. 8
    Street address - Persian: خیابان ولیعصر،کوچه 2 گاندی،پلاک 8
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 178651
    Phone: +98 21 8819 6862
    Fax:
    Email: kh.jadidi@gmail.com
    Web page address:
    Public
    Private
    Tabriz University of Medical Sciences
    Iranian academic center for education culture and research
    دانشگاه علوم پزشکی تبریز
    جهاد دانشگاهی

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahdieh Reyhani
    Full name of responsible person - Persian: مهديه ريحاني
    Position - English: Nutriotionist
    Position - Persian: تغذيه
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hospital Bina,Tehran
    Street address - Persian: تهران ،بیمارستان بینا
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1786521
    Phone: +98 21 23535
    Mobile: +98 912 849 0375
    Fax:
    Email: Mahdieh.reyhani@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Khosrow Jadidi
    Full name of responsible person - Persian: خسرو جدیدی
    Position - English: Corneal physician
    Position - Persian: پزشک فوق تخصص قرنیه
    Latest degree: med_doctor
    Area of specialty/work: 35
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: vision health research center
    Street address - Persian: مرکز سلامت بینایی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1786521
    Phone: +98 21 8819 6862
    Mobile: +98 912 105 3475
    Fax:
    Email: kh.jadidi@gmail.com
    Web page address:

Protocol summary

Study aim
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
Design
Clinical trial with community based and pragmatic control group, with parallel groups, three strains of blind, simple random
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Schirmer test, Tear Break Up Time, The degree of dry eye of the questionnaire, the mean staining corne, lipid profiles

General information

Reason for update
It needs to be updated due to changes
Acronym
IRCT registration information
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
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
Mahdieh Reyhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3384 4624
Email address
mahdieh.reyhani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-01, 1397/06/10
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
2018-09-01, 1397/06/10
Actual recruitment end date
2019-12-01, 1398/09/10
Trial completion date
2019-12-01, 1398/09/10
Scientific title
Effect of complementary supplementation Camelina Oil on the improvement of dry eye disease in patients with dry eye
Public title
Effect of complementary supplementation Camelina Oil on the improvement of dry eye disease in patients with dry eye
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 50
Actual sample size reached: 47
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, unit will be used individually and random numbers will be used
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants have a blinded role after informed consent, clinical care and outcome assessment
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical science
Street address
Central Organization2., Research Deputy., Univercity of Tabriz,
City
Tehran
Province
Tehran
Postal code
3357314
Approval date
2019-01-27, 1397/11/07
Ethics committee reference number
IR.TBZMED.REC.1397.890

Health conditions studied

1

Description of health condition studied
moderate dry eye
ICD-10 code
H04.1
ICD-10 code description
Other disorders of lacrimal gland Dacryops Dry eye syndrome

Primary outcomes

1

Description
schirmer test
Timepoint
5-10 mm
Method of measurement
Paper tape of schirmer

2

Description
tear break up time
Timepoint
5-10 second
Method of measurement
Coloring with fluorescein

Secondary outcomes

empty

Intervention groups

1

Description
Control group1: Capsule containing Comelina Oil, 0.5 grams, twice a day, 3 months, accompanied by breakfast and lunch, Vegeterian Company Barich Esanse
Category
Treatment - Drugs

2

Description
Control group2: Capsule containing paraffin oil, 0.5 grams, twice a day, 3 months, accompanied by breakfast and lunch ,Vegeterian Company Barich Esanse
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
vision health research center
Full name of responsible person
Khosrow Jadidi
Street address
Valiasr St., 2 Gandhi Alley, No. 8
City
Tehran
Province
Tehran
Postal code
17788561
Phone
+98 21 8819 6862
Email
kh.jadidi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
khosrow jadidi
Street address
Valiasr St., 2 Gandhi Alley, No. 8
City
tehran
Province
Tehran
Postal code
178651
Phone
+98 21 8819 6862
Email
kh.jadidi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdieh Reyhani
Position
Master
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Research Deputy., Central Office No.2, Tabriz University of Medical Sciences., Tabriz,
City
Tabriz
Province
Tehran
Postal code
0082149712
Phone
+98 0413357314
Email
mahdieh.reyhani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Khosrow Jadidi
Position
Corneal physician
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
vision health research center
City
Tehran
Province
Tehran
Postal code
1786521
Phone
+98 21 8819 6862
Fax
Email
kh.jadidi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdieh Reyhani
Position
Nutriotionist
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Hospital Bina, Tehran
City
Tehran
Province
Tehran
Postal code
178651
Phone
+98 21 23535
Fax
Email
Mahdieh.reyhani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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