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IRCT20200402046923N1 IRCT 2020-04-09 Tehran University of Medical Sciences Effect of herbal capsule, Viroherb, and herbal syrup, Fenugreek in treatment of COVID-19 Effects of Viroherb capsule and Fenugreek syrup derived from traditional Persian medicine on clinical and paraclinical outcomes and survival of patients with mild to moderate COVID-19 hospitalized in medical centers of Tehran University of Medical Sciences 2020-04-05 anticipated 110 Complete https://irct.ir/trial/46879 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment).The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of intervention and control (Assignment). Then based on blocks and allocation sequences medication will be given to patients. 3 COVID-19. Intervention 1: Intervention group: Medications in national guideline+ Viroherb capsule 500 mg 2 caps every 12 h + Fenugreek syrup 10 cc every 6 h. Intervention 2: Control group: Medications in national guideline. 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 Because it may be conducted some other researches on achieved data, it has not been made any decision about the publication of data.
public Roja Rahimi
Corner of Tabriz Ally, North Sarparast St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416663547 +98 21 8899 0835 rojarahimi@gmail.com Tehran University of Medical Sciences scientific Roja Rahimi
Tabriz Alley, North Sarparast St., Taleqani Ave.
Tehran Iran (Islamic Republic of) 1416663547 +98 21 8899 0835 rojarahimi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Ability to understand and the willingness to sign a written informed consent document Aged 18 and more without sex restriction patients with mild to moderate form of COVID-19 according to national guideline not recieved any retroviral or immunostimulant medications in the past 3 months 18 years no limit Both pregnancy or lactation patients in whom COVID-19 in not confirmed Alcohol or drug addiction patients with hypertension patients with peptic ulcer patients with diabetes U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Medications in national guideline+ Viroherb capsule 500 mg 2 caps every 12 h + Fenugreek syrup 10 cc every 6 h Control group: Medications in national guideline Body temperature. Timepoint: At the beginning of the study and on day 6. Method of measurement: thermometer. Adverse events. Timepoint: whole duration of study. Method of measurement: type and number of adverse event. Cough. Timepoint: At the beginning of the study and on day 6. Method of measurement: clinical judgement of physician. Dyspnea. Timepoint: At the beginning of the study and on day 6. Method of measurement: clinical judgement of physician. Myalgia. Timepoint: At the beginning of the study and on day 6. Method of measurement: Visual Analogue Scale. Liver enzymes (ALT, AST). Timepoint: At the beginning of study and day 6. Method of measurement: Laboratory refferal. Creatinine. Timepoint: At the beginning of study and day 6. Method of measurement: Laboratory refferal. Blood Gas ABG. Timepoint: At the beginning of study and day 6. Method of measurement: Laboratory refferal. Duration of hospital and ICU stay. Timepoint: At the end of study. Method of measurement: day(s). Complete blood count (CBC). Timepoint: At the beginning of study and day 6. Method of measurement: Laboratory refferal. Oxygen saturation. Timepoint: At the beginning of study and day 6. Method of measurement: Pulse oximetry. Tehran University of Medical Sciences Approved 2020-04-02 Ethics committee of Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)