Study of Evaluation of the therapeutic effects of Hab Shabyar on Intraocular pressure in patients with open-angle glaucoma: A double-blind clinical trial
This study is a double-blind randomized controlled clinical trial with two group. In this study, patients with open -angle glaucoma with IOP 11-21 mm Hg will be included to trial and patients that who have angle-closure glaucoma , ,Crohn's and Colitis Disease , hemorrhoids, use of systemic drugs to interfere with the IOP and pregnant women will be excluded from study.
In this study, fifty patients with open-angle glaucoma (IOP between 11-22 mm Hg) will be referred by an ophthalmologist or by group researchers will be invited with using the announcement and providing sufficient information. After obtaining written informed consent, eligible patients will be enrolled and randomly assigned to two groups. Random numbers table will be used for sample randomization and patients will be divided into two groups: interventional group (25 persons) and control group (25 persons). Control group will be received placebo and intervention group will be received shabyar pills for two months( once daily). In addition two group will be received conventional therapy (timolol every 12 hours). In fact, interventional group (with shabyar )and the control group (placebo)will be given placebo or shabyar for one month and after a month IOP will measure by Goldmann tonometer. Then, two group will be received placebo or shabyar for a month again. After this time, patients, intraocular pressure will be measured and recorded again for two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052828127N1
Registration date:2016-12-08, 1395/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-08, 1395/09/18
Registrant information
Name
Ebrahim khalil Banihabib
Name of organization / entity
Tabriz University of Medical-School of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 9527
Email address
banihabib.e@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor,Tabriz University of Medical Sciences
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Evaluation of the therapeutic effects of Hab Shabyar on Intraocular pressure in patients with open-angle glaucoma: A double-blind clinical trial
Public title
Evaluation of the therapeutic effects of Iranian Traditional Medicine (Hab Shabyar) in patients with open-angle glaucoma: A double-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age between 20-70 years; patients with open-angle glaucoma with IOP 11-21 mm Hg; patients with Informed consent.
Exclusion criteria: patients that who have angle-closure glaucoma; Crohn's and Colitis Disease; hemorrhoids; use of systemic drugs to interfere with the IOP and pregnant women.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
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
Used
Assignment
Parallel
Other design features
patients were randomly enrolled. Random method in survey is numbers table and patients will divide to two groups .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Postal code
5165665912
Approval date
2016-04-11, 1395/01/23
Ethics committee reference number
IR.TBZMED.REC.1395.9
Health conditions studied
1
Description of health condition studied
open-angle glaucoma
ICD-10 code
H40.1
ICD-10 code description
Primary open-angle glaucoma
Primary outcomes
1
Description
Intraocular pressure
Timepoint
Before the intervention, one month after and two months after intervention
Method of measurement
IOP measurement with Goldmann tonometer
Secondary outcomes
1
Description
side effects
Timepoint
One month and two months after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Control group: will be received placebo daily
Category
Placebo
2
Description
Intervention group: will be received shabyar pills daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharan Clinic of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Mostafaei
Street address
Baharan Clinic, Azadi Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
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 (VCR) of Tabriz 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
School of Traditional Medicine,Tabriz University of Medical Sciences
Full name of responsible person
Ebrahim khalil Banihabib
Position
MD PhD Student of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Tabriz University of Medical Sciences,Azadi Street, University Street, Tabriz,