To evaluate the efficacy and safety of crocin supplementation in patients with Central serous chorioretinopathy
Design
Two arms parallel-group randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
The patients will be enrolled from the ophthalmology retina clinic of Shiraz University of Medical Sciences and randomly allocated to the two study groups with blinding. Two study groups will be followed for 8 weeks and then assessed about outcomes of the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
age of 18-60 years old
The diagnosis of CSCR based on clinical and imagining evaluation
informed consent
Exclusion Criteria:
Chronic Central SerousChorioretinopathy
Laser treatment (6 months prior to enrollment)
Interaviteral treatment (3 months prior to enrollment)
Intervention groups
Crocin 15 mg/day for 8 weeks
Placebo 15 mg/day for 8 weeks
Main outcome variables
1. Best-corrected visual acuity
2. Foveal thickness in optical coherence tomography
3. Subretinal fluid height
4. Subfoveal choroidal thickness
5. Need to Laser Therapy after 2 months
6. Safety and tolerability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110811007297N7
Registration date:2021-06-22, 1400/04/01
Registration timing:prospective
Last update:2021-06-22, 1400/04/01
Update count:0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
Mojtaba Heydari
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7679
Email address
mheydari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-11-30, 1400/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Safety of Crocin Supplementation in Patients With Central SerousChorioretinopathy (CSCR)
Public title
Efficacy and Safety of Crocin Supplementation in Patients With Central SerousChorioretinopathy (CSCR)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age of 18-60 years old
The diagnosis of CSCR based on clinical and imagining evaluation
informed consent
Exclusion criteria:
Chronic Central SerousChorioretinopathy (CSCR)
Laser treatment (6 months prior to enrollment)
Intravitreal injection (3 months prior to enrollment)
Other retinal diseases
History of eye diseases
Diabetes Mellitus
Renal or hepatic diseases
Allergy to saffron or crocin
Pregnancy or lactation
Beta-blocker, diuretic, or corticosteroid (1 week prior to enrollment)
Bleeding tendency or any coagulation disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly allocated into two groups, by a secretary instructed to use a block-randomization list. The list will be generated by the computer as a non-stratified list, with the same block lengths.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding of the patients will be achieved by the similarity of drug and placebo.
Blinding of the outcome assessor will be achieved by not disclosing patients allocation group to the assessor.
Blinding of the statistician will be achieved by not disclosing data groups to him.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ُShiraz University of Medical Sciences
Street address
Zand St., infront of Flestin St., Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2021-04-17, 1400/01/28
Ethics committee reference number
IR.SUMS.REC.1400.059
Health conditions studied
1
Description of health condition studied
Central serous chorioretinopathy
ICD-10 code
H35.71
ICD-10 code description
Central serous chorioretinopathy
Primary outcomes
1
Description
Best-corrected visual acuity (BCVA)
Timepoint
8 weeks
Method of measurement
Snellen chart
2
Description
Foveal thickness
Timepoint
8 weeks
Method of measurement
Optical coherence tomography (OCT)
3
Description
Subretinal fluid height
Timepoint
8 weeks
Method of measurement
Optical coherence tomography (OCT)
4
Description
subfoveal choroidal thickness
Timepoint
8 weeks
Method of measurement
Optical coherence tomography (OCT)
5
Description
Need to Laser Therapy
Timepoint
8 weeks
Method of measurement
clinical evaluation
6
Description
Safety and tolerability
Timepoint
8 weeks
Method of measurement
based on patients reported adverse events
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Crocin one tablet 15 mg/day before breakfast for 2 months
Category
Treatment - Drugs
2
Description
Control group: Placebo one tablet 15 mg/day before breakfast for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Retina clinic, Shiraz University of Medical Sciences
Full name of responsible person
Mohammadkarim Johari
Street address
Zand st., infront of Felestin St., Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
mkjoharii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrzad Lotfi
Street address
Zand st., infront of Felestin St., Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
gsia@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Heydari
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand st., infront of Felestin St., Shiraz University of Medical Sciences