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IRCT20180103038199N13 IRCT 2023-02-28 Mashhad University of Medical Sciences Evaluation of effects of Covexir(R) on the immune system in healthy volunteers Evaluation of effects of Covexir(R) capsule on the immune system in healthy volunteers 2023-04-04 anticipated 32 Complete https://irct.ir/trial/68784 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 8 blocks according to the sample size of 32. Then random numbers between 1 and 8 are selected according to the randomization site Randomaization.com, and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 1 Healthy volunteers. Intervention 1: Intervention group: Healthy volunteers receiving Covexir at a dose of 350 mg once daily for 30 days. Intervention 2: Control group: Healthy volunteers receiving placebo capsules of the same shape and size as Covexir once a day for 30 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 It is not yet known.

public Vahid Reza Askari

Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad

Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv941@mums.ac.ir Mashhad University of Medical Sciences scientific Vahid Reza Askari

Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad

Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv941@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years old Healthy volunteers (Confirmed by history, physical examination and routine blood tests) Consent to admission to the study Three injections of the inactivated Covid-19 vaccines and at least two months have passed since the last injection. Not being infected with Covid-19 by using a rapid corona test and evaluating clinical symptoms. 18 years no limit Both Having any diseases Taking other medications Taking any herbal products and supplements Taking Covexir (R) within the previous 6 months Treatment - Drugs Placebo Intervention group: Healthy volunteers receiving Covexir at a dose of 350 mg once daily for 30 days. Control group: Healthy volunteers receiving placebo capsules of the same shape and size as Covexir once a day for 30 days. Evaluation of parameters related to the immune system (including hs-CRP level). Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Interleukin-6 level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Interleukin-10 level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. TNF-a level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Immunoglobulin-E level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Immunoglobulin-A level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Immunoglobulin-M level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Immunoglobulin-G level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Immunoglobulin-D level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Changes in CBC diff level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Alanine transaminase (ALT) level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Aspartate transaminase (AST) level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. BUN level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Creatinine level. Timepoint: At the beginning of the study and after 4 weeks of treatment. Method of measurement: Laboratory kit. Mashhad University of Medical Sciences Approved 2022-10-22 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)