Evaluation the effectineness of viola odorata almond oil nasal drop on eye dryness
Design
Randomized, parallel group clinical trial with double blinded
Settings and conduct
Negah hospital -Mostafa Khomeini hospital
The patient, the prescribe, as well as the person who analyze the data, do not know the type of treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- age between 30 to 70 years
2- Tear Break Up Time less than 10 seconds at least in one eye
3- schirmer test less than 10 mili meter at least in one eye without Local anesthesia
4- 2 symptoms of feeling eye dryness , foreign body sensation , eye burning Exclusion criteria :
1-Any active eye infection
2-Pregnancy or Lactation
3- Any anatomic disorder like entropion or ectropion
4-incoordination of patients
5-important surface diseases of eyes which affects test results
6-History of eye trauma during the past 2 months
7-Moderate to severe blepharitis
8-Refraction surgery or laser therapy of eyes during the past month
Intervention groups
Intervention group: Daily treatment with artificial tear and viola odorata almond oil drop intranasal 2 drops in each nostril at night before sleeping
category : Treatment - Drugs
Control group: Daily treatment with artificial tear and Normal Saline drop intranasal 2 drops in each nostril at night before sleeping
Category : Placebo
Main outcome variables
Eye dryness based on the score of questionaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181028041487N1
Registration date:2019-01-28, 1397/11/08
Registration timing:registered_while_recruiting
Last update:2019-01-28, 1397/11/08
Update count:0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
jamshid shayanfar
Name of organization / entity
Shahed university
Country
Iran (Islamic Republic of)
Phone
+98 21 4470 9236
Email address
shayanfarj@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of intra nasal viola odorata almond oil drop on dry eye disease
Public title
Evaluation the effect of intra nasal viola odorata almond oil drop on dry eye disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 30 to 70 years
TBUT<10 s at least in one eye
schirmer test < 10 mm at least in one eye without Local anesthesia
2 symptoms of feeling eye dryness , foreign body sensation, eye burning
Exclusion criteria:
Any active eye infection
Pregnancy or Lactation
Any anatomic disorder like entropion or ectropion
incoordination of patients
important surface diseases of eyes which affects test results
History of eye trauma during the past 2 months
Moderate to severe blepharitis
Refraction surgery or laser therapy of eyes during the past month
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are categorized to two groups A&B respectively based on attendance . The first female patient is allocated in group A and the second female patient is allocated in group B. Male patients also are allocated in two groups in a same way.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of drops is done by safety and data supervision committee.
Patients (treatment and control group) and the practitioner are blind about the interventions and administered drops.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahed university
Street address
Beginning of Tehran Qom freeway-Shahed university
City
Tehran
Province
Tehran
Postal code
1865133191
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
IR.Shahed.REC.1396.72
Health conditions studied
1
Description of health condition studied
EYE DRYNESS
ICD-10 code
H04.12
ICD-10 code description
Primary outcomes
1
Description
EYE DRYNESS
Timepoint
At the beginning of the study - After 3 weeks - After 6 weeks
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They get viola odorata almond oil 2 drops intra nasal for 6 weeks. Both placebo and drug are produced by Traditional medicine research center of Shahed university.
Category
Treatment - Drugs
2
Description
Control group: They get Normal Saline 2 drops intra nasal for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Negah hospital - Mostafa Khomeini hospital
Full name of responsible person
Dr Hassan Ghasemi
Street address
No. 3,Gol Nabi Ave., Ketabi Sq.,Negah hospital AND Italia Ave., Mostafa Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1416643491 -15449145
Phone
+98 21 23555
Fax
Email
shayanfarj@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr Ali Davati
Street address
Beginning of Tehran Qom freeway-Shahed university
City
Tehran
Province
Tehran
Postal code
1865133191
Phone
+98 21 5121 4055
Fax
+98 21 5121 4056
Email
a_davati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr Jamshid Shayanfar
Position
pHD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 60 , Shahrak Golestan , Golha Blvd.
City
Tehran
Province
Tehran
Postal code
1494744415
Phone
+98 21 5121 4056
Fax
+98 21 5121 4055
Email
shayanfarj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr Ali Davati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Beginning of Tehran Qom freeway-Shahed university
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 4056
Fax
+98 21 5121 4055
Email
a_davati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr Jamshid Shayanfar
Position
PHD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 60 , Shahrak Golestan , Golha Blvd.
City
Tehran
Province
Tehran
Postal code
1494744415
Phone
+98 21 5121 4056
Fax
+98 21 5121 4055
Email
shayanfarj@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available