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IRCT20201001048894N2 IRCT 2022-09-04 Bandare-abbas University of Medical Sciences Effects of Annual SZ drug on modulating immune responses and efficacy against COVID-19 infection Evaluation of the effects of Annual SZ drug on modulating immune responses and efficacy against COVID-19 infection: a randomized clinical trial 2022-09-23 anticipated 40 Complete https://irct.ir/trial/64765 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Randomization: In this study, we perform randomization using the method of Stratified Randomized Block Design. In this way, we use even blocks of four. In this section, we have two classes, one class has no history of receiving any vaccine and the other class has already received every dose of Sinopharm vaccine and more than 4 months have passed since their second dose. Then, in these two floors, we perform the randomized block method separately. The purpose of this work is to control the effect of vaccination, Blinding description: The study is a double-blind method using a placebo that has the same color, smell, and taste as the original drug but does not have the active ingredient. Also, Pharmaceutical packages will prepare in advance, and each patient will receive a unique code of Pharmaceutical package, so the treating physician does not know the package contents too. 2 Covid-19. Intervention 1: Intervention group: This group is infected with COVID-19 and receives Annual SZ as a treatment. This medicine is a herbal product obtained from the Sweet wormwood plant (with the scientific name Artemisia annua), its active ingredient is artemisinin. It has a concentration of 5mg/ml. The dosage for patients with the moderate stage of the disease is 2mg/kg/day, equivalent to 7 ml of syrup every 6 hours for 14 days. This drug is in the form of an oral syrup and it was produced by the university-based knowledge company of Salamat Zendegi Aramesh. Intervention 2: Control group: This group is infected with COVID-19 and receives the routine drugs of the national protocol as treatment. There is no intervention in this group. Yes - There is a plan to make this available What will be shared: only outcome information will be presented When: 3 month after publishing the results To whom: everyone Conditions: not restricted Where to obtain: ebtekarm@modares.ac.ir afshin.samiei@gmail.com How to obtain: sending an e-mail Comments:
public Masoumeh Ebtekar
Immunology Department, Faculty of Medical Sciences, Trabiat Modares University, Jalal AleAhmad St.
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3891 ebtekarm@modares.ac.ir Tarbiat Modares University scientific Masoumeh Ebtekar
Immunology Department, Faculty of Medical Sciences, Trabiat Modares University, Jalal AleAhmad St.
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3891 ebtekarm@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Individuals with COVID-19 disease or control group according to specified grouping Both genders from 20 to 50 years old Definite infection with COVID-19 (people whose PCR is positive, HRCT is clear evidence of infection and have common symptoms of moderate disease of Covid-19 Signing an informed consent form 20 years 50 years Both Age less than 20 years and more than 50 years Pregnancy People with cardiac arrhythmia, kidney, liver, metabolic or malignant diseases Mental or skin diseases (rash, dermatitis, psoriasis) Immunodeficiency diseases Acute patient conditions and severe illness, the patient has shortness of breath, blood oxygen drop and the disease is worsening U07.1 Covid 19 , Virus Identified Treatment - Drugs Treatment - Drugs Intervention group: This group is infected with COVID-19 and receives Annual SZ as a treatment. This medicine is a herbal product obtained from the Sweet wormwood plant (with the scientific name Artemisia annua), its active ingredient is artemisinin. It has a concentration of 5mg/ml. The dosage for patients with the moderate stage of the disease is 2mg/kg/day, equivalent to 7 ml of syrup every 6 hours for 14 days. This drug is in the form of an oral syrup and it was produced by the university-based knowledge company of Salamat Zendegi Aramesh. Control group: This group is infected with COVID-19 and receives the routine drugs of the national protocol as treatment. There is no intervention in this group. Immune system parameters. Timepoint: Before intervention and 7, 14 days after intervention. Method of measurement: Using flow cytometry and enzyme-linked immunosorbent assay (ELISA) tests. Tarbiat Modares University Bandare-abbas University of Medical Sciences Tarbiat Modares University Approved 2022-08-27 Research Ethics committees of Tarbiat Modares University Jalal AleAhmad Tehran Tehran Iran (Islamic Republic of)