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IRCT20200415047083N1 IRCT 2020-07-14 Shiraz University of Medical Sciences Evaluation of the effect of Garlic tablet as a treatment of macular edema of patients with diabetic retinopathy Evaluation of the effect of Garlic tablet as a complementary treatment of macular edema of patients with diabetic retinopathy in comparison with placebo, double blind randomized placebo controlled clinical trial 2020-07-22 anticipated 96 Complete https://irct.ir/trial/47451 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In each clinic a random number (for example between 0-1) is produced by calculator or computer for each patient and if this number is lower than a limit number ( for example 0.5) that patient is selected as a case and if upper as a control or viceversa. Or : A number is allocated to each patient .Random numbers( equal to number of case or control group) produced by using calculator or computer .Patients are divided into two groups by using random numbers, Blinding description: In this study, patients were randomly assigned to two groups: case and control. All patients receive standard treatment for macular diabetic edema (intravenous injection of Bevacizumab or retinal laser) under the supervision of a physician. The therapist has no information about the case and control individuals.patients on the case group are given garlic tablets at a dose of 1000 mg daily for 4 weeks (if possible 2or 3 months for some patients). The other group is given a placebo in the form of a pill with the same packaging as the Garlic supplement. 3 Macular edema in patients with diabetes. Intervention 1: Intervention group: A complete examination of the anterior and posterior segments is performed for patients in this group. and the best corrected visual acuity is measured based on the Snellen chart, and optical coherence tomography is done for all the patients. All patients receive standard treatment for macular diabetic edema (intravenous injection of Boasizumab or retinal laser). Patients in the intervention group receive Garlic tablet with a dose of 1000 mg daily with lunch for 1 month (if possible for some patients 2 or 3 months).After 1 month, the best corrected visual acuity and optical coherence tomography is performed and macula thickness is measured. Intervention 2: Control group: A complete examination of the anterior and posterior segments is performed for patients in this group. and the best corrected visual acuity is measured based on the Snellen chart, and optical coherence tomography is done for all the patients. All patients receive standard treatment for macular diabetic edema (intravenous injection of Boasizumab or retinal laser). Patients in the control group receive placebo tablet daily with lunch for 1 month (if possible for some patients 2 or 3 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 Dissatisfaction of some patients and colleagues.
public Elham sadegi
Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7134997446 0987132330073 elham.sadeghi@rocketmail.com Shiraz University of Medical Sciences scientific Mehrdad Afarid
Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7134997446 0987132330073 afaridm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Diabetic patients with macular edema no limit no limit Both Oral or intravenous injection of corticosteroids and Immunomodulatory therapy History of vitrectomy surgery Warfarin and Plavix and Heparin History of chemotherapy and active gastrointestinal ulcers History of cerebral hemorrhage E11.311 Diabetes mellitus with unspecified diabetic retinopathy with macular edema Treatment - Drugs Treatment - Drugs Intervention group: A complete examination of the anterior and posterior segments is performed for patients in this group. and the best corrected visual acuity is measured based on the Snellen chart, and optical coherence tomography is done for all the patients. All patients receive standard treatment for macular diabetic edema (intravenous injection of Boasizumab or retinal laser). Patients in the intervention group receive Garlic tablet with a dose of 1000 mg daily with lunch for 1 month (if possible for some patients 2 or 3 months).After 1 month, the best corrected visual acuity and optical coherence tomography is performed and macula thickness is measured. Control group: A complete examination of the anterior and posterior segments is performed for patients in this group. and the best corrected visual acuity is measured based on the Snellen chart, and optical coherence tomography is done for all the patients. All patients receive standard treatment for macular diabetic edema (intravenous injection of Boasizumab or retinal laser). Patients in the control group receive placebo tablet daily with lunch for 1 month (if possible for some patients 2 or 3 months). Macula thickness. Timepoint: Before starting the intervention and 1 month later after taking garlic tablets and placebo. Method of measurement: Optical coherence tomography. Best Corrected Visual Acuity. Timepoint: Before starting the intervention and 1 month later after taking garlic tablets and placebo. Method of measurement: Snellen chart. Shiraz University of Medical Sciences Approved 2020-04-26 Ethics committee of Shiraz University of Medical Sciences Department of Ophthalmology, Poostchi Ophthalmology Research Center, Asadabadi Ave., Zand Blvd., Shiraz, Shiraz Fars Iran (Islamic Republic of)