Evaluation of efficacy of Topical Timolol for treatment in conjunctival Pyogenic Granuloma in patients reffer to farshchian hospital 2022
Design
Phase 2-3 clinical trial is conducted on 46 patients without randomization and blinding.
Settings and conduct
This clinical trial study is conducted on pyogenic granuloma patients in Farshchian Hospital, Hamedan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pyogenic granuloma; Consent to participate in the study
Exclusion criteria: Pregnancy; Presence of previous similar lesions; Lost follow-up after 6 weeks.
Intervention groups
Intervention group: 46 patients with pyogenic granuloma of the eye conjunctiva will be treated with 5% topical timolol drops made by Sina Daro pharmaceutical company(Iran) twice a day for 3 to 6 weeks.
Main outcome variables
Lesion improvement, lesion recurrence and complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N27
Registration date:2023-01-13, 1401/10/23
Registration timing:prospective
Last update:2023-01-13, 1401/10/23
Update count:0
Registration date
2023-01-13, 1401/10/23
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-25, 1401/11/05
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of Topical Timolol for treatment in conjunctival Pyogenic Granuloma
Public title
Evaluation of efficacy of Topical Timolol for treatment in conjunctival Pyogenic Granulom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pyogenic granuloma
Consent to participate in the study
Exclusion criteria:
Pregnancy
Presence of previous similar lesions
Lost of follow-up after 6 week.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.UMSHA.REC.1401.833
Health conditions studied
1
Description of health condition studied
Pyogenic granuloma
ICD-10 code
L98.0
ICD-10 code description
Pyogenic granuloma
Primary outcomes
1
Description
Lesion healing
Timepoint
6 weeks after treatment
Method of measurement
Eye examination
2
Description
Recurrence of the lesion
Timepoint
6 weeks after treatment
Method of measurement
Eye examination
Secondary outcomes
1
Description
Complication
Timepoint
12 weeks after treatment
Method of measurement
Eye examination
Intervention groups
1
Description
Intervention group: 46 patients with pyogenic granuloma of the eye conjunctiva will be treated with 5% topical timolol drops made by Sina Daro pharmaceutical company(Iran) twice a day for 3 to 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Fatemeh Eslami
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
hrgb2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
hrgb2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Eslami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
hrgb2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamiad Salehei
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
hamidsalehi853@gmail.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