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IRCT20200503047280N1 IRCT 2020-06-02 Tabriz University of Medical Sciences Effect of Laris-Teucrium Polium L.and Laris-Hyssop combined herbal medicine on the prevention of covid-19 disease Effect of Laris-Teucrium Polium L.and Laris-Hyssop combined herbal medicine on the prevention of covid-19 disease in high risk people exposed for corona virus: A randomized controlled field trial. 2020-05-09 anticipated 300 Complete https://irct.ir/trial/47704 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Six and nine blocking with allocation ratio of 1: 1: 1 into three groups consisting of two intervention groups and one control group Darnma using computer software RAS (Random Allocation Software), Blinding description: Laris-Teucrium Polium L.and Laris-Hyssop, and placebo drugs will be prepared in exactly similar 500 ml bottles and will be numbered based on random allocation sequences. Drug recipients, researchers, data analysts, and data monitoring and safety boards will be blind to the received intervention. 3 COVID-19. Intervention 1: First intervention group: Laris-Tokrium polium compound herbal medicine. This compound will be prepared as a herbal distillate in 500 cc bottles by Sarab Production and Service Company. The appearance of the drug is designed to be the same in all three groups. Two will be given to each eligible person to take 5 (under 12 years) or 10 (over 12 years) CC of this drug orally daily between meals for 20 days. . Volunteers involved in the intervention of healthy people are exposed to the infected person and will not be sick to receive routine treatment. After the end of the consumption period, data collection and final analysis takes place. Intervention 2: First intervention group: Laris-Tokrium Hisspus compound herbal medicine. This compound will be prepared as a herbal distillate in 500 cc bottles by Sarab Production and Service Company. The appearance of the drug is designed to be the same in all three groups. Two will be given to each eligible person to take 5 (under 12 years) or 10 (over 12 years) CC of this drug orally daily between meals for 20 days. . Volunteers involved in the intervention of healthy people are exposed to the infected person and will not be sick to receive routine treatment. After the end of the consumption period, data collection and final analysis takes place. Intervention 3: Control group: placebo. The ineffective solution, which will be prepared by a fellow pharmacist, will be used in similar bottles and similar appearance specifications with drugs from other groups and with the same recipe. Volunteers involved in the intervention of healthy people are exposed to the infected person and will not be sick to receive routine treatment.After the end of the consumption period, data collection and final analysis takes place. 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 At the moment, I have not made a decision due to the current study conditions at the university
public Seyyed mohammad bagher fazljou
Faculty of Traditional Medicine-Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3337 9527 dr.fazljou@yahoo.com Tabriz University of Medical Sciences scientific Seyyed mohammad bagher fazljou
Faculty of Traditional medicine- Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5165665931 0098413339527 dr.fazljou@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) High-risk people exposed to the corona virus Older than 7 years Having an informed consent form to participate in the study Not participation in another simultaneous clinical trial 7 years no limit Both Pregnant women Breastfeeding women Having liver or renal failure, according to the individual or family declaration U07.1 COVID-19, virus identified Prevention Prevention Prevention First intervention group: Laris-Tokrium polium compound herbal medicine. This compound will be prepared as a herbal distillate in 500 cc bottles by Sarab Production and Service Company. The appearance of the drug is designed to be the same in all three groups. Two will be given to each eligible person to take 5 (under 12 years) or 10 (over 12 years) CC of this drug orally daily between meals for 20 days. . Volunteers involved in the intervention of healthy people are exposed to the infected person and will not be sick to receive routine treatment. After the end of the consumption period, data collection and final analysis takes place. First intervention group: Laris-Tokrium Hisspus compound herbal medicine. This compound will be prepared as a herbal distillate in 500 cc bottles by Sarab Production and Service Company. The appearance of the drug is designed to be the same in all three groups. Two will be given to each eligible person to take 5 (under 12 years) or 10 (over 12 years) CC of this drug orally daily between meals for 20 days. . Volunteers involved in the intervention of healthy people are exposed to the infected person and will not be sick to receive routine treatment. After the end of the consumption period, data collection and final analysis takes place. Control group: placebo. The ineffective solution, which will be prepared by a fellow pharmacist, will be used in similar bottles and similar appearance specifications with drugs from other groups and with the same recipe. Volunteers involved in the intervention of healthy people are exposed to the infected person and will not be sick to receive routine treatment.After the end of the consumption period, data collection and final analysis takes place. Symptoms of corona-virus. Timepoint: Day 5, 10, 15 and 20 of the taking combined herbal medicine. Method of measurement: Corona-virus Symptoms Questionnaire. Side effects. Timepoint: During and at the end of intervention. Method of measurement: Side effects questionnaire. Satisfaction with drug use. Timepoint: At the end of intervention. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2020-04-21 Ethics Committee of Tabriz University of Medical Sciences Faculty of Traditional Medicine, Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)