pseudoexfoliation glaucoma patients whose IOP is under control with timolol and dorzolamide will be divided randomly in two 15 person groups, first group will receive oral placebo daily , secound group will receive saffron capsules(30 mg) daily. intraocular pressure will be messured at first, 7th and 30th day and after one month of wash out period . If both eyes of one patient had glaucoma only one eye randomly will be entered in study. intraocular pressure values of these groups will be studied.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308298832N2
Registration date:2013-09-22, 1392/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Mohammad Hossein Jabbarpoor Bonyadi
Name of organization / entity
Gonabad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 9012
Email address
drbonyadi@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University Of Medical Sciences
Expected recruitment start date
2013-09-09, 1392/06/18
Expected recruitment end date
2014-03-03, 1392/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral saffron extract effect on intraocular pressure in pseduexfoliation glaucoma patients
Public title
Evaluation of oral saffron extract effect on intraocular pressure in pseduexfoliation glaucoma patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : pseudoexoliation glaucoma controlled with topical timolol bd and dorzolamid tds ; age >50
exclusion criteria: angle closure glaucoma; systemic componding medication
Age
From 50 years old to 120 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical sciences, Gadir square,Gonabad, Khorasan razavi Iran, Islamic Republic Of
City
Gonabad
Postal code
Approval date
2012-02-01, 1390/11/12
Ethics committee reference number
90/1/1
Health conditions studied
1
Description of health condition studied
pseudoexfoliation glaucoma
ICD-10 code
H40.5
ICD-10 code description
Glaucoma secondary to other eye disorders
Primary outcomes
1
Description
Intraocular pressure
Timepoint
baseline, 1rst ,7th,21st and 28 day and after one month wash out
Method of measurement
Goldmann tonometry
Secondary outcomes
1
Description
Intraocular pressure
Timepoint
baseline, 1rst third fourth week and after one month wash out
Method of measurement
goldmann tonometery
Intervention groups
1
Description
Placebo capsules for 30 days then 1 month wash out
Category
Treatment - Drugs
2
Description
Saffron 30 mg/daily every day for 30 days then 1 month of wash out period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Mohammad Hossein Jabbarpoor Bonyadi
Street address
Naser khosro Ave, 22 Bahman Hospital
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Hossein Jabbarpoor Bonyadi
Street address
22 Bahman Hospital Naser khosro avenue
City
Gonabad,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
ohammad Hossein Jabbarpoor Bonyadi
Position
ophthalmologist
Other areas of specialty/work
Street address
Gadir square, Gonabad
City
Gonabad
Postal code
Phone
+98 53 3722 6921
Fax
+98 533722901200
Email
drbonyadi@gmu.ac.i
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Hossein Jabbarpoor Bonyadi
Position
Ophthalmologist
Other areas of specialty/work
Street address
22 Bahman Hospital
City
Gonabad
Postal code
Phone
+98 53 3722 6921
Fax
Email
mhbonyadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University Of Medical Sciences
Full name of responsible person
Mohammad Hossein Jabbarpoor Bonyadi
Position
Ophthalmologist
Other areas of specialty/work
Street address
Gonabad, Gadir square
City
Gonabad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)