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IRCT20160131026298N4 IRCT 2020-08-04 Bagheiat-allah University of Medical Sciences Evaluation of the effectiveness of Cyclotide complex herbal syrup in preventing COVID-19 virus in exposed individuals Pilot clinical trial to evaluate the effectiveness of Herbal Cyclotide complex syrup as a prevention of disease complications in people exposed to COVID-19 virus 2020-04-20 anticipated 60 Complete https://irct.ir/trial/49925 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be by block randomization (quadruple random blocks). Randomization units are individuals. 60 outpatients referred to the hospital emergency department are allocated in one of the two intervention and control groupsaccording to form of random string produced by online random allocation . This study is a non-concealed method and people in the intervention group will receive the intervention drug to prevent COVID-19 complications, but in the control group the drug is not used. 2-3 COVID-19 viral disease. Intervention 1: Intervention group: Consumable product includes herbal syrup composed of cyclopeptide fraction with Ziziphus spina-cristi and Pimpinela anisum hydroalcoholic extract and orange peel. The dose of the product is 20 ml every 8 hours after eating, which is prepared by Herbi Pharmed Pharmaceutical Company. Intervention 2: Control group: do not use any drugs for prevention and only follow health protocols to prevent infection. No - There is not a plan to make this available Justification or reason for not sharing IPD is Pay attention to organizational rules
public Shiva Shamshiri
No.4, Gholhak Ave, Shari'ati Blvd
Tehran Iran (Islamic Republic of) 1913844819 +98 21 2642 1927 shiva.shamshiri90@yahoo.com Tehran University of Medical Sciences scientific shiva shamshiri
No.4, Gholhak Ave, Shari'ati Blvd
Tehran Iran (Islamic Republic of) 1913844819 +98 21 2642 1927 shiva.shamshiri90@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) People over the age of 18 who have had close contact with a person with COVID-19 in the last 4 days and signed an informed consent form (close contact is defined as those who live at home with an infected person or depending on their employment situation in Less than two meters away from the infected person.) And have no previous or current history of COVID-19. Age between 18 and 70 years No previous diagnosis of COVID-19 (if possible, test negative for IgG and IgM antibodies.) Absence of symptoms such as fever, body aches, olfactory and taste disturbances, cough, shortness of breath, diarrhea in the last 1 month 18 years 70 years Both Current incidence of COVID-19 is confirmed by PCR and clinical signs. History of autoimmune disease History of rheumatic disease Pregnancy and lactation Age under 18 years People sensitive to any component of the product People who can not follow up. Any clinical reason that may prevent you from entering the study. Do not take two doses of the drug B34.2 Coronavirus infection, unspecified Prevention Prevention Intervention group: Consumable product includes herbal syrup composed of cyclopeptide fraction with Ziziphus spina-cristi and Pimpinela anisum hydroalcoholic extract and orange peel. The dose of the product is 20 ml every 8 hours after eating, which is prepared by Herbi Pharmed Pharmaceutical Company. Control group: do not use any drugs for prevention and only follow health protocols to prevent infection. Polymerase chain reaction (PCR) analysis result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Polymerase chain reaction (PCR) analysis. Liver function test result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Measurement of aspartate aminotransferase (AST) and Alanine transaminase (ALT) factors. Fragment D-dimer test result. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Blood test - Fragment D-dimer measurement. Measurement of serum iron. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Blood test - Total iron binding capacity factor (TIBC) measurement. COVID-19 Antibodies. Timepoint: At the beginning of the intervention and the day 14. Method of measurement: Measurement of IgG COVID-19 and IgM COVID-19 factors. Herbi Pharmed pharmaceutical company Approved 2020-06-21 Ethics Committee of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Shaikh Bahai St., Vanak Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)