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IRCT20201219049753N2 IRCT 2022-09-12 Mashhad University of Medical Sciences Evaluation of the effect of crocin in the treatment of cystoid macular edema secondary to retinitis pigmentosa Evaluation of the effect of crocin in the treatment of cystoid macular edema secondary to retinitis pigmentosa : randomized clinical trial 2022-09-22 anticipated 20 Complete https://irct.ir/trial/65530 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The study includes two intervention and control groups, both groups receive the conventional treatment for cystoid macular edema, but in the intervention group, crocin tablets are also prescribed in addition to the conventional treatment, Randomization description: Randomization will be done using PASS software. In this way, the studied groups (coded) and the number of patients in each group will be entered into the software and a random sequence will be generated. The sequences are placed in closed envelopes in the same order as they were produced by a person who is not in the course of the study. In such a way that the contents of the envelopes cannot be seen from the outside. The envelopes are numbered. Then for each patient who meets the entry criteria An envelope will be opened and based on the contents of the envelope, a person will be entered into the intervention or control group. All steps of sequence generation and allocation of patients to groups and concealment of allocation will be done by someone who is not in the course of the study, Blinding description: In this study, patients, clinical care and outcome assessors are kept blind. And they are not aware of the content of drug packages and the allocation of patients to intervention and control groups. The drug and placebo are similar in terms of color, shape and smell. 2-3 Retinitis pigmentosa. Intervention 1: Intervention group :Patients with typical retinitis pigmentosa, over 18 years of age, who have macular cystoid edema (CMT above 296 microns in OCT or the presence of cysts in OCT) and meet the conditions for entering the study after an educational session about RP disease and complications Prescription drugs, side effects and how to use them, crocin tablets at the rate of 15 mg daily orally are started for them. In addition to crocin tablets, they also receive the conventional treatment of this condition, which is ketorolac and dorzolamide eye drops. The duration of treatment is three months. Crocin tablets contain the active ingredient crocin, the most important active ingredient in saffron.This drug is produced in poyesh daroye Sina Company. Intervention 2: Control group: patients with typical retinitis pigmentosa, over 18 years of age, who have macular cystoid edema (CMT above 296 microns in OCT or the presence of a cyst in OCT) and meet the conditions for entering the study after an educational session about RP disease and complication , prescription drugs, side effects and how to use them are treated with ketorolac and dorzolamide eye drops and placebo. The duration of treatment is three months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: The start of the access period is after the results are published. To whom: Researchers working in academic and scientific institutions can have access. Conditions: They can use the data to get acquainted with the type of data classification and statistical analysis. Where to obtain: Sending an email to the researcher in charge of the study zamanigh@mums.ac.ir How to obtain: The request will be sent via an email to the researcher in charge of studying, and after reviewing the request by the research team and final approval, the data will be sent within a month. Comments:
public Mehdi eslami shoabjareh
NO. 4, Kafaei St
Mashhad Iran (Islamic Republic of) 9183784398 +98 51 3728 1401 mehdi1989eslami@gmail.com Mashhad University of Medical Sciences scientific Mehdi eslami shoabjereh
No .4, Kafaei St
Mashhad Iran (Islamic Republic of) 9183784398 +98 51 3728 1401 mehdi1989eslami@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with typical retinitis pigmentosa with increased central macular thickness They have not received treatment for this condition in the last 3 months They have the ability to understand the study and the power to choose to participate in the study. 18 years no limit Both History of diabetes Recent ocular surgery pregnancy and lactation period History of taking drugs that cause macular edema in the last 3 months Suffering from other eye diseases that lead to macular cystoid edema H35.5 Hereditary retinal dystrophy Treatment - Drugs Treatment - Drugs Intervention group :Patients with typical retinitis pigmentosa, over 18 years of age, who have macular cystoid edema (CMT above 296 microns in OCT or the presence of cysts in OCT) and meet the conditions for entering the study after an educational session about RP disease and complications Prescription drugs, side effects and how to use them, crocin tablets at the rate of 15 mg daily orally are started for them. In addition to crocin tablets, they also receive the conventional treatment of this condition, which is ketorolac and dorzolamide eye drops. The duration of treatment is three months. Crocin tablets contain the active ingredient crocin, the most important active ingredient in saffron.This drug is produced in poyesh daroye Sina Company Control group: patients with typical retinitis pigmentosa, over 18 years of age, who have macular cystoid edema (CMT above 296 microns in OCT or the presence of a cyst in OCT) and meet the conditions for entering the study after an educational session about RP disease and complication , prescription drugs, side effects and how to use them are treated with ketorolac and dorzolamide eye drops and placebo. The duration of treatment is three months. The CMT in OCT. Timepoint: The central thickness of the macula in OCT at the beginning of the study before the intervention and at the end of the first, second and third month. Method of measurement: Macular OCT. Size of cysts in the macula oct. Timepoint: At the beginning of the study before the intervention and at the end of the first, second and third month. Method of measurement: macula oct. Best corrected visual acuity (BCVA). Timepoint: Best corrected visual acuity (BCVA) at the beginning of the study before the intervention and at the end of the first, second and third month. Method of measurement: Optometry. Liver function tests. Timepoint: before the intervention and at the end of the study. Method of measurement: chemistry analyzer. Kidney function tests. Timepoint: before the intervention and at the end of the study. Method of measurement: chemistry analyzer. Fasting blood lipid profile. Timepoint: before the intervention and at the end of the study. Method of measurement: chemistry analyzer. Fasting blood sugar. Timepoint: before the intervention and at the end of the study. Method of measurement: chemistry analyzer. Complete blood count. Timepoint: before the intervention and at the end of the study. Method of measurement: hematology analyzer. Mashhad University of Medical Sciences Approved 2022-04-18 Ethics Committee of Mashhad University of Medical Sciences Faculty of Medicine Ethics committee, Medical sciences faculty, Pardis, Vakil abad blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)