This clinical trial study was done on 32 patients with Blepharitis problem occurred in the center of Kerman University of Medical Sciences.
One eye was selected as a control group and the second eye was selected as an interventional group.
Every eye had the more symptoms was selected for treatment with Al-Ethmed Kohl's and second eye was treated with erythromycin ointment. Shampoo every night before taking the drug and Fluocort drops every 12 hours was used in both groups.
Inclusion criteria included the presence of anterior and posterior Blepharitis, Chalazion in one or both eyes, and blepharitis patients with symptoms of allergic conjunctivitis and other diseases or any disease of the anterior surface of the eye are excluded.
The primary outcome of the study include the recovery rate Blepharitis and Chalazion treatment Al-Ethmed Kohl's.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208017219N4
Registration date:2016-02-12, 1394/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-12, 1394/11/23
Registrant information
Name
Esmat Karbassi
Name of organization / entity
Kerman Medicine University
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 1132
Email address
mkarbasi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial about comparison of novel treatment with Kohl Al-Ethmed and conventional Antibiotic therapy on patients with Blepharitis
Public title
Kohl Al-Ethmed in treatment of inflammation of the eyelid.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: anterior or posterior blepharitis in one or both eyes, recurrent chalazion.
Exclusion criteria: allergic blepharitis or conjunctival inflammatory disease, and the other anterior segment diseases of the eyes.
Age
From 5 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Tahmasb Abad St. Kerman
City
Kerman
Postal code
Approval date
2012-02-05, 1390/11/16
Ethics committee reference number
10/61/1902
Health conditions studied
1
Description of health condition studied
Blepharitis
ICD-10 code
H01.0
ICD-10 code description
blepharoconjunctivitis
Primary outcomes
1
Description
Chalazion
Timepoint
Before Intervention , one month and two months after intervention
Method of measurement
Clinical examination with Slit lamp
2
Description
Blepharitis
Timepoint
before intervention, one month and two months after intervention
Method of measurement
Clinical examination with Slit Lamp
Secondary outcomes
1
Description
Eyelash loss
Timepoint
before intervention, one month and two months after intervention
Method of measurement
Clinical examination with Slit Lamp
2
Description
Keratitis
Timepoint
Before Intervention , one month and two months after intervention
Method of measurement
Clinical examination with Slit Lamp
Intervention groups
1
Description
kohl Al-Ethmed which was taken from the Saudi Arabia`s mountain and produced in powder form inside Dan kohl in the Faculty of Pharmacy, Kerman University of Medical Science.
Polished in the eyelids margin every night once a month.
Category
Treatment - Drugs
2
Description
The usual treatment in the other eye is taking erythromycin ointment in the eyelids margin every night once a month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital, Kerman University of Medical Sciences
Full name of responsible person
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Ehsan Ziasistani
Street address
2th, Jomhori Blvd. Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Karbasi Esmat
Position
Oculoplastic and Strabismus Fellowship
Other areas of specialty/work
Street address
Department of Ophthalmology, Shafa Hospital, Kerman
City
Kerman
Postal code
Phone
+98 34 1211 5786
Fax
Email
sh_karbassi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Karbasi Esmat
Position
Oculoplastic and Strabismus Fellowship
Other areas of specialty/work
Street address
Shafa Blvd. Kerman
City
Kerman
Postal code
Phone
+98 34 1211 5786
Fax
Email
Sh_karbassi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamze Saleh
Position
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)