Objectives:evaluation the effect of honey on corneal ulcer design:All patients that enrolled in this study are from patients that are reffered to eye emergency setting and conduct: all patients were reffered due to metalic foreign body with corneal ulcer major inclusion and exclusion criteria:ulcers less than 2 mm that are not in center of cornea without anterior chamber reaction.
Patients are randomly divided into 2 groups.for 1 group we will start topical ciprofloxacine and for the other group topical honey is applied.smear and culture are taken before starting drops. Main outcome measures variables:in antibiogram (MIC) honey is checked.all patients will be examined daily for depth and size of ulcer and progression.the honey drop is completely filtered and is antiseptic.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020120892N1
Registration date:2015-10-11, 1394/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-11, 1394/07/19
Registrant information
Name
Mahmood Nejabat
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
soltan_k@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, shiraz university of medical sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison the therapeutic effect of honey drop and ciprofloxacin drop in corneal ulcer
Public title
Clinical trial of comparison the effect of honey drop and ciprofloxacin drop in corneal ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All patients that enrolled in this study are from patients that are reffered to eye emergency due to metalic foreign body; with corneal ulcer less than 2 mm; that are not in center of cornea without anterior chamber reaction.
Exclusion criteria:corneral ulcers that located in center of cornea;or non metalic; or larger than 2 mm; or in the presence if anterior chamber reaction.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients are randomly divided into 2 groups،according to closed pockets.for 1 group we will start topical ciprofloxacine and for the other group topical honey is applied.smear and culture are taken before starting drops.in antibiogram (MIC) honey is checked.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7193616641
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.SUMS.REC.1394.2
Health conditions studied
1
Description of health condition studied
Corneal ulcer
ICD-10 code
H16.0
ICD-10 code description
Corneal ulcer
Primary outcomes
1
Description
size of ulcer.inflammation.epithelial healing
Timepoint
1st,3rd,7th and 10th
Method of measurement
Slit Lamp and questionaeer
Secondary outcomes
1
Description
Allergy to Honey
Timepoint
The Patient is Observed and Also alarm signs are taken to them
Method of measurement
With Clinical Exam
Intervention groups
1
Description
Intervention group 1: the patients that recieve topical honey drop 7o %( manufactured by pharmacologic center of Shiraz university of medical sciences).In this group drop of honey Every6 hours will be applies.intervention
Category
Treatment - Drugs
2
Description
Intervention group 2: The patient that receive Ciprofloxacin 0.3 (Sina darou company, Teh-IR, with IRC1228036651). In this group drop of Ciprofloxacin will be applied every 6 hours.all of the patients will be examined until the ulcer become improved totally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Doctor Mahmood Nejabat
Street address
Shiraz, Khalili Street, Khalili Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Doctor Sayed Basir Hashemi
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Grant name
پابان نامه دانشجویی
Grant code / Reference number
91-01-01-4982
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mahmood Nejabat
Position
Asociated Professor Of Ophthalmology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
Nejabatm@sums.ac.ir
Web page address
Psorc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mahmood Nejabat
Position
Cornea fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
nejabatm@sums.ac.ir
Web page address
Psorc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Mahmood Nejabat
Position
Asociated Professor Of Ophthalmology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
nejabatm@sums.ac.ir
Web page address
Psorc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)