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The Ocular Hypotensive Effect of Saffron Extract in Primary Open Angle Glaucoma: a Pilot Study

Protocol summary

Summary
Open angle glaucoma patients under control with timolol and dorzolamide divided 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 wash out. 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: IRCT201201278832N1
Registration date: 2012-12-19, 1391/09/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-19, 1391/09/29
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
2012-02-22, 1390/12/03
Expected recruitment end date
2012-12-02, 1391/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Ocular Hypotensive Effect of Saffron Extract in Primary Open Angle Glaucoma: a Pilot Study
Public title
Evaluation of saffron effect on intraocular pressure in glaucoma patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria :open angle glaucoma; age >50 exclusioncriteria: angle closure glaucoma; systemic componding medication
Age
From 50 years old
Gender
Both
Phase
2
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 Medical University
City
Gonabad, Gadir square
Postal code
Approval date
2012-02-01, 1390/11/12
Ethics committee reference number
90/1

Health conditions studied

1

Description of health condition studied
primary open angle glaucoma
ICD-10 code
H40.1
ICD-10 code description
Primary open-angle glaucoma

Primary outcomes

1

Description
intraocular pressure
Timepoint
baseline,7th,21th and 28th day after 1 month wash-out
Method of measurement
goldmann tonometery

Secondary outcomes

empty

Intervention groups

1

Description
placebo capsule daily
Category
Treatment - Drugs

2

Description
saffron capsule daily( 30 mg)
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
Gonabad, Naser khosro Ave
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
City
Gonabad, Naser khosro avenue
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
Mohammad Hossein Jabbarpoor Bonyadi
Position
ophthalmologist
Other areas of specialty/work
Street address
Gadir square Gonabad
City
Gonabad
Postal code
Phone
+98 53 3722 9012
Fax
Email
drbonyadi@gmu.ac.ir
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 9012
Fax
Email
drbonyadi@gmu.ac.ir
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
22 Bahman Hospital
City
Gonabad
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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