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IRCT20200504047295N1 IRCT 2020-09-16 Ahvaz University of Medical Sciences Effectiveness of Shallomin syrup on patients affected by COVID-19 Evaluation effectiveness of Shallomin syrup compared with current treatment protocol on the elimination of clinical symptoms and duration of hospitalization in admitted patients with COVID-19: A double-blind, parallel-group, multicenter, and randomized controlled trial 2020-08-10 anticipated 90 Complete https://irct.ir/trial/47661 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This parallel-group, double-blind, and the randomized controlled trial is randomized by designing a table using blocks of size 6. The randomization unit was the individual, the randomization sequence was created using WinPEPI program (version 11.43) and was stratified with a 1:1 allocation using a random block of size 6, and allocation concealment was done by assigning unicodes, Blinding description: Double-blinded: The way of blinding this is that the main investigator and the participants are unaware of the prescription drug. The drugs of both groups are in the containers of a dark color and in the same odor and color. The syrups are distinguished only by mentioning the number, and the list of numbers are given to the statistical consultant for subsequent data analysis. 3 COVID-19. Intervention 1: Intervention group: COVID-19 patients will receive 10 ml of shalomin syrup every 6 hours for six days. Intervention 2: Control group: COVID-19 patients will be treated with placebo syrup, 10 ccs per 6 hours for six days. Yes - There is a plan to make this available What will be shared: Duration of hospitalization, death, clinical symptoms, age and sex of COVID-19 patients. When: during the next 4 months To whom: All of the people Conditions: For treatment of the patients Where to obtain: Through emailing to corresponding author How to obtain: Supplementary data will be available only for qualified enthusiastic researchers Comments:
public Mansour Amin
Ahvaz Jundishapur University of Medical Sciences, School of Medicine, Microbiology Department, Golestan Ave., Medical Sciences Blvd., Ahvaz Town., Khuzestan Province., Iran
Ahvaz Iran (Islamic Republic of) 61357-15753 +98 916 305 1096 mnsamin@yahoo.com Ahvaz University of Medical Sciences scientific Mansour Amin
Ahvaz Jundishapur University of Medical Sciences, School of Medicine, Microbiology Department, Golestan Ave., Medical Sciences Blvd., Ahvaz Town., Khuzestan Province., Iran
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 916 305 1096 amin-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) COVID-19 patients who have clinical signs of COVID-19 infection such as fever, cough, sputum production, sore throat. Patients with the positive CT scan Patients with the positive RT-qPCR for corona virus 2019 Patients who declare informed consent for enrollment in this study. 18 years 75 years Both Pregnant women (based on WHO protocol) Lactating women (based on WHO protocol) Individuals who exhibit specific allergic reactions to shallomin syrup. Patients with heart failure, kidney failure, hepatitis, hemophilia, thalassemia or leukemia U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Intervention group: COVID-19 patients will receive 10 ml of shalomin syrup every 6 hours for six days. Control group: COVID-19 patients will be treated with placebo syrup, 10 ccs per 6 hours for six days. Hospitalization duration. Timepoint: About one week after starting the treatment. Method of measurement: Clinical and laboratory questionnaire. Death in hospital. Timepoint: About one week after starting the treatment. Method of measurement: vital signs. Blood oxygen saturation. Timepoint: Every day. Method of measurement: Pulse blood oximeter. Fever. Timepoint: Every day. Method of measurement: Oral thermometer. Complete Blood Count (CBC). Timepoint: The first and end of intervention week. Method of measurement: H one devise. Erythrocyte sedimentation rate (ESR). Timepoint: The first and end of intervention week. Method of measurement: Sediment pipette. Ahvaz University of Medical Sciences Approved 2020-03-04 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan boulevard Ahvaz Khouzestan Iran (Islamic Republic of)