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IRCT20150815023620N9 IRCT 2021-03-13 Shahid Beheshti University of Medical Sciences Evaluation of the effect of herbal food product in patients with COVID 19 Evaluation of the effect of herbal food product (Shad syrup) in patients with COVID 19 2020-04-01 anticipated 150 Complete https://irct.ir/trial/52045 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With simple randomization and using a random number table and individual randomization unit. To randomize, we use a table consisting of random digits 0 to 9. Each digit of this table is repeated the same on average. There is no pattern of recognizable numbers. In this method, each number is assigned to a treatment group. We start from the first line of the table and move down line by line. For the two treatments, we put the numbers 0 to 4 for treatment A and the numbers 5 to 9 for treatment B. The numbers in the first line of the table are as follows: 0,5,2,7,8,4,3,7,4,1,6,8,3,8,5,1,5,6,9,6, ... Now for people based on the above numbers, we have the following allocation: A, B, A, B, B,... We will continue the above process until the two groups are completed. 3 COVID-19. Intervention 1: Intervention group: Shad syrup. The dosage of the syrup is 5 cc with 10 cc of water every 4 hours for the first two days and 5 cc every 6 hours for the next two days, which is given to the patient by the ward nurse and its consumption is monitored. Intervention 2: Control group: placebo. The dose is equivalent to non-drug syrup for the first two days every 4 hours 5 cc with 10 cc of water and the next two days every 6 hours 5 cc which is given to the patient by the ward nurse and its consumption is monitored. Yes - There is a plan to make this available What will be shared: some of information of main outcome will share When: from 2021 To whom: researchers in universities Conditions: use of all shared data is allowed with permission Where to obtain: dr reza moshari rmoshari@sbmu.ac.ir How to obtain: send an emal and take a permission Comments:
public Dr Mohammadreza Moshari
Taleghani Educational Hospital, Shahid Aarabi Ave, Yaman St, Chamran High Way
Teharn Iran (Islamic Republic of) 1985711151 +98 21 2243 2595 Rmoshari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammadreza Moshari
Velenjak
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2595 rmoshari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) confirmed COVID-19 infection with Lab tests not considering sign and symptoms suspected COVID-19 infection based on national protocol include the patients who has respiratory signs and pulmonary unilateral or bilateral multilobar infiltration in CT scan or chest radiography suspected patient to pneumonia with uncommon rapid deterioration and fast worsening of clinical status and not responding to proper treatments age 30 to 65 30 years 60 years Both late visit more than 5 days of onset of symptoms pregnancy and breastfeeding alergy history complicated bacterial infection severe and critical patients ( ARDS and MODS ) patient in recovery phase U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Shad syrup. The dosage of the syrup is 5 cc with 10 cc of water every 4 hours for the first two days and 5 cc every 6 hours for the next two days, which is given to the patient by the ward nurse and its consumption is monitored. Control group: placebo. The dose is equivalent to non-drug syrup for the first two days every 4 hours 5 cc with 10 cc of water and the next two days every 6 hours 5 cc which is given to the patient by the ward nurse and its consumption is monitored. Death. Timepoint: daily. Method of measurement: Patient record. Fever (temperature ). Timepoint: Daily. Method of measurement: Thermometer. SPO2. Timepoint: Daily. Method of measurement: Pulse oximetry. CRP. Timepoint: Daily. Method of measurement: Biochemical testing. ESR. Timepoint: Daily. Method of measurement: ESR Reader. LDH. Timepoint: Daily. Method of measurement: Biochemical testing. SGPT. Timepoint: Daily. Method of measurement: Biochemical testing. SGOT. Timepoint: Daily. Method of measurement: Biochemical testing. BUN. Timepoint: Daily. Method of measurement: Biochemical testing. Cr. Timepoint: Daily. Method of measurement: Biochemical testing. Sbmu Univercity Approved 2020-05-30 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences Anesthesiology Research Center,Taleghani Hospital Tehran, Iran Tehran Tehran Iran (Islamic Republic of)