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IRCT2015062113058N2 IRCT 2015-07-24 Vice Chancellor for Research of Mashhad University of Medical Sciences Effects of ‍ Crocin on Diabetic Retinopathy and Cataract Effects of ‍ Crocin on Diabetic Retinopathy and Cataract; A Double Blind Placebo Controlled Randomized Clinical Trial 2015-07-23 anticipated 60 Complete https://irct.ir/trial/13000 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study of patients in the treatment groups and the placebo group are randomly assigned . Doctors have no information of intervention . 2-3 Diabetic Retinophaty. Intervention 1: Group 1:Included Patients With 5 mg per Day Of Crocin. Intervention 2: Intervention Group 2: Patients With 15 mg per Day Of Crocin. Intervention 3: DiabeticPpatients With Placebo For 3 Months Treatments.
public Dr.Seyed Ahmad Mohajeri
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) +98 51 3882 3255 mohajeria@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Seyed Ahmad Mohajeri
School of Pharmacy, Mashhad University of Medical Sciences, Vakil Abad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9196773117 +98 51 3882 3255 mohajeria@mums.ac.ir PhD in Pharmacology, Faculty Member of Pharmacodynamy and Toxicology, School of Pharmacy and Targete Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Adult patients (18 ≤) with type 1 and 2 diabetes and CSME (clinically significant macular edema) according to ETDRS criteria (early treatment diabetic retinopathy study) in the studied eye, or patients who are diagnosed with cataract as well as central macular thickness in OCT above 296 microns, well controlled diabetes mellitus (HbA1c less than or equal to 8.5 over the last 3 months), and the ability to understand overview of the study, treatment and possible side effects. For cataract patients:Patients who are scheduled to undergo cataract surgery in the next 3 months and are not in a state of emergency. Grading based on a 0 to 4, according to criteria:0 = lens normal, clear, 1 = lens shows a slight blur, 2 = lens represents darkness average, 3 = lens represents the darkness of and the details are, 4 = Lens indicator cataract is done Exclusion criteria: 1. Presence of other eye abnormalities (non-retina causes, etc.) that despite an improvement in macular edema, do not improve visual acuity. 2. Other eye diseases (retinal vein occlusion, uveitis, retinal epithelial membrane) that can affect macular edema. 3. Patients with anterior segment abnormalities of the eye (cornea, anterior chamber, iris, or lens) 4. History of vitrectomy 5. Subfoveal hard exudates deposition 6. Existence treatment required PDR 7. Intraocular surgery within the last 3 months 8. Pregnancy 9. Vitreous hemorrhage 18 years 75 years Both *H36.0 Diabetic Retinopathy Treatment - Drugs Treatment - Drugs Treatment - Drugs Group 1:Included Patients With 5 mg per Day Of Crocin. Intervention Group 2: Patients With 15 mg per Day Of Crocin. DiabeticPpatients With Placebo For 3 Months Treatments. Central Macular Thickness. Timepoint: Before Intervention, and After Three Months. Method of measurement: Spectralis OCT Device. Measure The Opacity Of The Lens. Timepoint: At The Time Of The Visit And Once After Of The End Of Treatment Period. Method of measurement: Microscopes Equipped With Digital Cameras And Upper Ring Light. Side effects of crocin. Timepoint: Before intervention,and three months later. Method of measurement: Questionnaire for side effect of crocin. Vice Chancellor for Research of Mashhad University of Medical Sciences Approved 2014-12-10 Mashhad University of Medical Science Deputy of Science and Technology, Mashhad University of Medical Sciences, next to the Hoveizeh cinema, Daneshgah Avenue Mashhad Iran (Islamic Republic of)