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IRCT20130418013058N15 IRCT 2020-10-26 Mashhad University of Medical Sciences The effect of crocin on retinal arteries Evaluation of the effect of crocin on macular, peripapillary and optic nerve head blood flow in healthy individuals using coherence tomography optical angiography (OCTA) 2020-08-22 anticipated 40 Complete https://irct.ir/trial/49234 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: four-digit numbers, obtained from “random number table”, will be applied for coding of tablet containers and randomization. First column of the random number table will be assigned to crocin group and the second one to placebo. The codes will be written on a piece of paper and put into an opaque envelope. The envelopes will be sealed and placed sequentially in a box and kept by researcher and physician. Envelopes and their code will be assigned sequentially to eligible participants in order of their arrival time, Blinding description: Crocin and placebo tablets will be prepared in a similar shape, color, and size, stored in a dark container and coded by a pharmacist. The physician, researcher, and participants will not be aware of the content of the pills inside the container. 2 The blood flow of the macula, peripapillary and head of optic nerve. Intervention 1: Intervention group: Two crocin tablets (15 mg) will be given into healthy participants in the project. Optical coherence tomography (OCT) imaging with angiography will be done before and after two hours of crocin administration. Intervention 2: Control group: Two placebo tablets will be given into healthy participants in the project. Optical coherence tomography (OCT) imaging with angiography will be done before and after two hours of placebo administration, . Yes - There is a plan to make this available What will be shared: Primary and secondary outcome data and demographic data When: 6 months after publication of the results To whom: Researchers and who works in pharmaceutical industries Conditions: Analysis and interpretation of data is allowed. Where to obtain: Dr. Seyed Ahmad Mohajeri, email: mohajeria@mums.ac.ir, tel: 098-51-31801181 How to obtain: The data request must be sent by email and the documents of the applicant must be attached. If approved the data will be sent within a month. Comments:
public Seyed Ahmad Mohajeri
Faculty of Pharmacy, Azadi sq.
Mashhad Iran (Islamic Republic of) 9188617871 +98 51 3180 1181 mohajeria@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Ahmad Mohajeri
Faculty of Pharmacy, Azadi sq.
Mashhad Iran (Islamic Republic of) 9188617871 +98 51 3180 1181 mohajeria@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The age of the volunteer should be between 20 and 50 Lack of systemic disease such as diabetes and hypertension Do not use systemic drugs Lack of any intraocular pathology No history of eye surgery 20 years 50 years Both Any eye disease Age less than 20 or more than 50 History of eye surgery Treatment - Drugs Treatment - Drugs Intervention group: Two crocin tablets (15 mg) will be given into healthy participants in the project. Optical coherence tomography (OCT) imaging with angiography will be done before and after two hours of crocin administration. Control group: Two placebo tablets will be given into healthy participants in the project. Optical coherence tomography (OCT) imaging with angiography will be done before and after two hours of placebo administration, . Macular blood flow. Timepoint: Before the intervention and two hours after taking 2 tablets of 15 mg crocin or placebo. Method of measurement: Coherence Optical Tomography Angiography (OCTA). Blood flow of peripapillary and optic nerve head. Timepoint: Before the intervention and two hours after taking two tablets of crocin or placebo. Method of measurement: Coherence Optical Tomography Angiography (OCTA). Mashhad University of Medical Sciences Approved 2020-05-01 Ethics committee of Mashhad University of Medical Sciences School of Pharmacy, Ferdowsi University complex, Azadi square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)