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IRCT20210803052060N1 IRCT 2021-09-12 Artesh University of Medical Sciences Effect of Terminalia chebula, Pistacia lentiscus and brown sugar oral combination in covid-19 treatment Evaluating the effect of Terminalia chebula, Pistacia lenticus and brown sugar oral preparation onrespiratory clinical findings and inflammatory indicators in patients with COVID-19 2021-08-11 anticipated 200 Complete https://irct.ir/trial/57872 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using MATLAB software version R2018b, 200 people are randomly divided into two groups of 100 intervention (A) and control (B) using randperm(n, k) command. The randperm(n, k) command randomly extracts a non-duplicate number from range 1 to n. Thus, each of the numbers 1 to 200, which represent 200 patients, can be assigned to only one of the groups A or B. There is no specific pattern for assigning to each of the groups, and only by referring to the file extracted from the program command, you can find the assignment of each number to each of groups A or B. Thus, patient number 1 is given a code 1 drug package. The medicine package is filled based on the extracted file by a person who is not involved in the research process, Blinding description: In this study, according to the use of random number method and similarity of drug and placebo, only by referring to the Excel file of random division can be aware of the presence of the person in the intervention or control group. Access to this file is only possible for the drug packer who is not present during the project implementation process. Therefore, the patient and all medical staff of the hospital, including the evaluator, are kept blind to the study groups. 3 new Corona virus disease 2019. Intervention 1: Intervention group: COVID-19 standard treatment based on the protocol recommended by the Ministry of Health for hospitalized patients (remdesivir, prophylactic anticoagulant, and low dose corticosteroids) and tablets obtained from a combination of Terminalia chebula, Pistacia lentiscus, and brown sugar oral preparation, one tablet every 6 hours for 5 days (750 mg tablets prepared in the Department of Pharmacy, AJA University of Medical Sciences). Intervention 2: Control group: COVID-19 standard treatment based on the protocol recommended by the Ministry of Health for hospitalized patients (remdesivir, prophylactic anticoagulant, and low dose corticosteroids) and placebo, one tablet every 6 hours for 5 days (Starch tablets prepared in the Department of Pharmacy, AJA University of Medical Sciences). Yes - There is a plan to make this available What will be shared: Data is shared after deleting personal information When: Late 2021 To whom: Everyone Conditions: Free access Where to obtain: responsible auther How to obtain: Request from the responsible author Comments:
public Sajjad Panahi
West Fatemi St., Etemad Zadeh St., AJA University of Military Medical Sciences
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 s.panahi777@yahoo.com Artesh University of Medical Sciences scientific Nafiseh Hosseini Yekta
West Fatemi St., Etemad Zadeh St., AJA University of Military Medical Sciences
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 nhyekta@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Men and women above 18 years with positive PCR test for Covid-19 At least two of these findings: GGO>10%, SO2<93%, RR>20, at least one underlying disease (COPD, HF, HTN, DM, Asthma, Immunodeficiency) Conscious written consent to participate in the study 18 years no limit Both Covid vaccination history Participation in another clinical trial U07.1 new Corona virus disease 2019 Treatment - Drugs Placebo Intervention group: COVID-19 standard treatment based on the protocol recommended by the Ministry of Health for hospitalized patients (remdesivir, prophylactic anticoagulant, and low dose corticosteroids) and tablets obtained from a combination of Terminalia chebula, Pistacia lentiscus, and brown sugar oral preparation, one tablet every 6 hours for 5 days (750 mg tablets prepared in the Department of Pharmacy, AJA University of Medical Sciences) Control group: COVID-19 standard treatment based on the protocol recommended by the Ministry of Health for hospitalized patients (remdesivir, prophylactic anticoagulant, and low dose corticosteroids) and placebo, one tablet every 6 hours for 5 days (Starch tablets prepared in the Department of Pharmacy, AJA University of Medical Sciences). ICU admision or intubation. Timepoint: During hospitalization, daily. Method of measurement: Evaluator report. Clinical symptoms(The degree of shortness of breath, cough intensity). Timepoint: During hospitalization, daily. Method of measurement: Symptoms by asking the patient as a scale indicator and signs by monitoring the patient by the assessor. Inflammatory markers (ESR, CRP, LDH, WBC). Timepoint: before and after the 5 days intervention. Method of measurement: Quantitative laboratory measurements of blood samples. Clinical examinations (RR, SO2). Timepoint: During hospitalization, daily. Method of measurement: Through clinical examination and use of pulse oximeter. Artesh University of Medical Sciences Approved 2021-07-03 Research Committees of AJA University of Medical Sciences West Fatemi St., Etemad Zadeh St., AJA University of Military Medical Sciences Tehran Tehran Iran (Islamic Republic of)