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IRCT20131125015536N13 IRCT 2020-10-03 Tehran University of Medical Sciences Assessment of the effect of nanocurcumin supplement in patients with COVID-19 Effect of nanocurcumin supplementation on the severity of symptoms and length of hospital stay in patients with COVID-19 2020-05-21 anticipated 48 Complete https://irct.ir/trial/51310 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done by permuted block method. First, all possible quadruple blocks are considered and a number is assigned to each of them. Then, using a table of random numbers and the number assigned to each block, a random sequence is determined. Eligible individuals included in the study are placed in the intervention or control group according to the sequence determined based on randomization, Blinding description: In order to keeping patients, clinical caregivers, and the outcome assessor blind, the placebo will be prepared of the same color and shape as the supplement so that no one could distinguish the supplement from the placebo. The main researcher, who is not in direct contact with patients, is the only person who is not blind and pours supplements and placebos into exactly the same cans, specifies the cans with a three-digit number in no particular order and gives the cans to the outcome assessor, who is responsible for entering patients into the study and giving them the supplements. The randomization sequence will be kept by the main researcher, and he/she will inform the outcome assessor that which can (based on the three-digit code) should be given to the next patient. In this way, the outcome assessor is not able to interfere with the order of patients' entering and will be completely blind to the contents of the can that should be given to the next patient. N/A COVID-19. Intervention 1: Intervention group: People in the intervention group will receive nanocurcumin supplement at a dose of 160 mg per day for 6 days. Curcumin is a natural polyphenolic antioxidant responsible for the turmeric yellow color. Nanocurcumin supplements are produced in the form of 40 mg capsules by Exir Nano Sina Company, and patients will receive 4 supplements orally (every 12 hours 2 capsules) for 6 days in addition to the routine treatment,. Intervention 2: Control group: People in the control group are given placebo capsules that are completely similar to nanocurcumin supplements in terms of shape and color and are asked to take 4 placebo capsules daily (every 12 hours 2 capsules) for 6 days. 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 -
public Mohammad Javad Hossein Zadeh
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) - +98 21 8895 5975 mhosseinzadeh@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Javad Hossein Zadeh
School of Nutritional Sciences and Dietetics, No. 44, Hodjat doost Alley, Naderi St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) - +98 21 8895 5975 mhosseinzadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmation of Covid-19 by positive PCR test or lung scan Admission to hospital Corona wards other than ICU Filling out the informed consent form by the patient or the patient's first-degree relatives 30 years 70 years Both Chemotherapy People living with HIV History of heart attack and stroke in the last 3 months History of CABG Dialysis patients Transplantation of body organs Pregnancy and lactation People with BMI above 40 Known food allergies Having any liver failure Malignancies Uncontrolled Diabetes (A1c>7.5) U07.1 Coronavirus infection, unspecified Rehabilitation Placebo Intervention group: People in the intervention group will receive nanocurcumin supplement at a dose of 160 mg per day for 6 days. Curcumin is a natural polyphenolic antioxidant responsible for the turmeric yellow color. Nanocurcumin supplements are produced in the form of 40 mg capsules by Exir Nano Sina Company, and patients will receive 4 supplements orally (every 12 hours 2 capsules) for 6 days in addition to the routine treatment,. Control group: People in the control group are given placebo capsules that are completely similar to nanocurcumin supplements in terms of shape and color and are asked to take 4 placebo capsules daily (every 12 hours 2 capsules) for 6 days. Hs-CRP. Timepoint: Before and after 6 days of supplementation. Method of measurement: ELISA. Percentage of recovery. Timepoint: Before and after 6 days of supplementation. Method of measurement: CT scan of the lungs. Percentage of oxygen saturation. Timepoint: Before the intervention and then daily until discharge. Method of measurement: Pulse oximeter. Severity of infection symptoms of upper and lower respiratory tract. Timepoint: Before the intervention and then daily during the supplementation period. Method of measurement: Questionnaire. Complete Blood Count. Timepoint: Before and after 6 days of supplementation. Method of measurement: Automated cell count. Tehran University of Medical Sciences Approved 2020-04-26 Ethics Committee on Research, Research and Technology Department of Tehran University of Medical Sci Floor 6, Central Organization of University, corner of Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)