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IRCT20110811007297N7 IRCT 2021-06-22 Shiraz University of Medical Sciences Efficacy and Safety of Crocin Supplementation in Patients With Central SerousChorioretinopathy (CSCR) Efficacy and Safety of Crocin Supplementation in Patients With Central SerousChorioretinopathy (CSCR) 2021-07-01 anticipated 40 Complete https://irct.ir/trial/55779 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Central serous chorioretinopathy. Intervention 1: Intervention group: Crocin one tablet 15 mg/day before breakfast for 2 months. Intervention 2: Control group: Placebo one tablet 15 mg/day before breakfast for 2 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mojtaba Heydari
Zand st., infront of Felestin St., Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 7135744661 +7136201913 mheydari@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammdkarim Johari
Zand st., infront of Felestin St., Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶ - ۷۱۳۴۸ +98 71 3230 5410 mkjoharii@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) age of 18-60 years old The diagnosis of CSCR based on clinical and imagining evaluation informed consent 18 years 60 years Both 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 H35.71 Central serous chorioretinopathy Treatment - Drugs Treatment - Drugs Intervention group: Crocin one tablet 15 mg/day before breakfast for 2 months Control group: Placebo one tablet 15 mg/day before breakfast for 2 months Best-corrected visual acuity (BCVA). Timepoint: 8 weeks. Method of measurement: Snellen chart. Foveal thickness. Timepoint: 8 weeks. Method of measurement: Optical coherence tomography (OCT). Subretinal fluid height. Timepoint: 8 weeks. Method of measurement: Optical coherence tomography (OCT). Subfoveal choroidal thickness. Timepoint: 8 weeks. Method of measurement: Optical coherence tomography (OCT). Need to Laser Therapy. Timepoint: 8 weeks. Method of measurement: clinical evaluation. Safety and tolerability. Timepoint: 8 weeks. Method of measurement: based on patients reported adverse events. Shiraz University of Medical Sciences Approved 2021-04-17 Ethics committee of ُShiraz University of Medical Sciences Zand St., infront of Flestin St., Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)