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IRCT20210926052587N1 IRCT 2022-07-16 Semnan University of Medical Sciences Evaluation of the effect of saffron extract and vitamin A supplement in the control and treatment of dry eye symptoms Evaluation of the effect of saffron extract and vitamin A supplement in the control and treatment of dry eye symptoms in patients referred to the Visual Health Center 2021-11-22 anticipated 120 Complete https://irct.ir/trial/59859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 1000 is prepared in an incoherent and scattered manner, and the numbers are assigned to four groups of 30 people by intervention and control software. The randomization process is studied by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 1000, Blinding description: one ‘active’ pill and one ‘placebo’ pill. As they are physically identical, it is impossible for patients and researchers to discern which pill is the active one based on appearance alone. 2-3 Dry eye syndrome. Intervention 1: 30 patients are randomly assigned to the control group and receive placebo for 90 days or 3 months. Each placebo capsule contains 35 mg of microcrystalline cellulose, maltodextrin and magnesium stearate. The usual placebo group will receive artificial tears. The capsules are prepared by Sina Pajouhan Salamat Pharmaceutical Company. Each group of volunteers receives standardized doses under the supervision of specialists. And the method of consumption is one capsule every 12 hours. For each volunteer participating in the study, a training session will be conducted to review the objectives of this study, interventions and follow-up and treatment will be done on day zero. Participants can also contact the patient follow-up officer (Mohammad Mehdi Johari Moghadam) during the study. Take the necessary follow-up. The course will last 90 days and the results of the study will be shared with all patients at the end of the study. Intervention 2: Intervention group: First (second group of saffron supplement 70 mg per day) - 30 patients are randomly placed in intervention group 1 and receive the capsule for 90 days or 3 months. Each capsule contains 35 mg of saffron, which will be used orally and one capsule every 12 hours. Intervention 3: Intervention group: Second (vitamin A supplement one mg per day) 30 patients are randomly assigned to the second intervention group and receive the capsule for 90 days or 3 months. Each capsule contains 500 micrograms of vitamin A. Intervention 4: Third intervention group (vitamin A supplement of one mg with saffron 70 mg per day): 30 patients are randomly placed in the third intervention group and receive the capsule for 90 days or 3 months. Each capsule contains 500 micrograms of vitamin A and 35 mg (70 mg per day) of saffron. Capsules will be taken orally and one capsule every 12 hours. Yes - There is a plan to make this available What will be shared: The results of the data will be shared with the participants after the study and analytical review When: Access is allowed from the beginning of 2022 To whom: Researchers in the field of ophthalmic surgery Conditions: Adequate knowledge and previous background in ophthalmic research Where to obtain: Mohammad Mehdi Johari Moghaddam Email address: Mohamadmehdi.jm@gmail.com How to obtain: Request an email and send a resume and reason Comments:
public Khosrow Jadidi
Unit 17, 5th Floor, No. 8, 2nd alley, in front of Dey Hospital, above Tavanir Intersection, Valiasr St., Tehran
Tehran Iran (Islamic Republic of) 1516747418 +98 21 8819 6871 kh.jadidi@gmail.com The Vision Health Center of Tehran, Iran scientific Mohammad Mehdi Johari Moghadam
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 mohamadmehdi.jm@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria are patients with dry eye. Thus, if a person has a Schmermer test (or SMTUBE) (with anesthesia) less than 10 mm and a tear film rupture test (TBUT) less than 10 seconds, it is a diagnosis of dry eye and will be included in the study. 18 years 70 years Both Previous history of eye surgery Previous history of eye disorders Systemic disorders Using a contact lense (including soft or hard type) Failure to fill out the informed consent form H04. 129 Dry eye syndrome of unspecified lacrimal gland Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs 30 patients are randomly assigned to the control group and receive placebo for 90 days or 3 months. Each placebo capsule contains 35 mg of microcrystalline cellulose, maltodextrin and magnesium stearate. The usual placebo group will receive artificial tears. The capsules are prepared by Sina Pajouhan Salamat Pharmaceutical Company. Each group of volunteers receives standardized doses under the supervision of specialists. And the method of consumption is one capsule every 12 hours. For each volunteer participating in the study, a training session will be conducted to review the objectives of this study, interventions and follow-up and treatment will be done on day zero. Participants can also contact the patient follow-up officer (Mohammad Mehdi Johari Moghadam) during the study. Take the necessary follow-up. The course will last 90 days and the results of the study will be shared with all patients at the end of the study. Intervention group: First (second group of saffron supplement 70 mg per day) - 30 patients are randomly placed in intervention group 1 and receive the capsule for 90 days or 3 months. Each capsule contains 35 mg of saffron, which will be used orally and one capsule every 12 hours. Intervention group: Second (vitamin A supplement one mg per day) 30 patients are randomly assigned to the second intervention group and receive the capsule for 90 days or 3 months. Each capsule contains 500 micrograms of vitamin A. Third intervention group (vitamin A supplement of one mg with saffron 70 mg per day): 30 patients are randomly placed in the third intervention group and receive the capsule for 90 days or 3 months. Each capsule contains 500 micrograms of vitamin A and 35 mg (70 mg per day) of saffron. Capsules will be taken orally and one capsule every 12 hours. Dry eye (in the present study, dry eye based on the results of the Surface Eye Disease Index (OSDI≥13) and TBUT non-invasive (less than 10 seconds), Shermer 1 test (with anesthesia) less than 10 mm and color Eye surface plasticity (OSS) will be defined (color>> 5 corneal points and> 9 conjunctival or eyelid edge points). Timepoint: Measurement of dry eye at the beginning of the study (before the intervention) and 90 days after the start of medication. Method of measurement: (in the present study, dry eye based on the results of the Surface Eye Disease Index (OSDI≥13) and TBUT non-invasive (less than 10 seconds), Shermer 1 test (with anesthesia) less than 10 mm and color Eye surface plasticity (OSS) will be defined (color>> 5 corneal points and> 9 conjunctival or eyelid edge points). Best corrected visual acuity. Timepoint: Day 0 and Day 90. Method of measurement: Snellen chart. Semnan University of Medical Sciences Approved 2021-12-09 Ethics Committee of Semnan University of Medical Sciences and Health Services Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran. Semnan Semnan Iran (Islamic Republic of)