The aim of this study was to investigate the effect of crocin as an effective anti-inflammatory and anti-oxidant saffron agent in preventing possible damage to neurons and retinal tubules and consequent irreversible blindness in glaucoma. In this double blind clinical trial, the sample size was taken using the Sigma Plot software.40 patients with open angle glaucoma who have an upper IOP of 21 and no history of surgery and divided into two groups of 20, one in the intervention group of crocin 15 mg and the other in the placebo group.For uniformity and double blind of the study, placebo tablets are in the same size and shape as the crocin tablets.The internal pressure of the eye, the nerve fibers of the patient's nerve before the intervention, the end of the two months and the end of the 4 months in both groups are examined.Also, the possible side effects of crocin in this trial will be questioned by each patient.t is hoped that the crocin tablet can be used as a supplement in the future as a routine for the treatment of open angle glaucoma.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030113058N6
Registration date:2017-09-17, 1396/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-17, 1396/06/26
Registrant information
Name
Seyed Ahmad Mohajeri
Name of organization / entity
Pharmaceutical Research Center, School Of Pharmacy, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohajeria@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Science
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Crocin on patient with open angle glaucoma by double blinded, randomized and placebo-controlled clinical trial
Public title
Effect of Crocin on patient with open angle glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients (40 years and older) with open angle glaucoma; The ability to understand the generalities of study,Interventions and possible complications; Eye pressure (IOP) above 21 with or without treatment; cup-to-disc ratio ≥0.4>0.8; Similarity of glaucoma intensity in two eyes.
Exclusion criteria: The presence of eye disease and the use of steroids that can affect eye pressure; History of intraocular surgery and laser therapy; Pregnancy and breastfeeding; Saffron sensitivity; Advanced glaucoma at the bedside, based on prime criteria (It is done for all patients with glaucoma routinely).
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Mashhad University of Medical Science
Street address
Deputy of Science and Technology, Mashhad University of Medical Sciences, next to the Hoveizeh cinema, Daneshgah Avenue
City
Mashahd
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUMS.SP.1395.70
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
Two months before and two months after treatments
Method of measurement
Tonometer
2
Description
Retinal nerve fiber layer
Timepoint
Before the intervention and at the end of month 2 and 4 months later
Method of measurement
RNFL OCT
Secondary outcomes
1
Description
ُُSide effects of crocin
Timepoint
Before intervention, and two and four months later
Method of measurement
Questionnaire for side effect of crocin
Intervention groups
1
Description
Treatment Group: Patients with open angle glaucoma that used 15 mg per day of crocin tablet with the routine treatment of open-angle glaucoma drug. Crocin is a full herbal medicine constitute of saffron.
Category
Treatment - Drugs
2
Description
Control group: Patients with open angle glaucoma that used one placebo tablet per day with routine drugs of glaucoma.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Al-Anbia Hospital
Full name of responsible person
Dr. Saeed Shokouhi
Street address
Abotaleb Intersection toward Ferdosi Square.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ahmad Mohajeri, Dr. Mohsen Tafaghodi
Street address
Shahid Fakori Blvd., Between shahis Javan and Shahid Al-Shahidi, Mashhad
City
Mashahad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ahmad Mohajeri
Position
PhD in Pharmacology, Faculty Member of Pharmacodynamy and Toxicology, School of Pharmacy and Targete
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3251
Fax
Email
mohajeria@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
PhD in Pharmacology, Faculty Member of Pharmacodynamy and Toxicology, School of Pharmacy and Targete
Full name of responsible person
Dr. Seyed Ahmad Mohajeri
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3251
Fax
Email
mohajeria@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Of Medical Science
Full name of responsible person
Samaneh Sepahi
Position
Other areas of specialty/work
Street address
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)