Evaluating the effect of Terminalia chebula, Pistacia lenticus and brown sugar oral preparation onrespiratory clinical findings and inflammatory indicators in patients with COVID-19

Determining the effect of T.chebula, P.lentiscus and brown sugar on clinical respiratory findings and inflammatory markers in patients with Covid 19

Clinical trial with control group, with parallel intervention group, double-blind (patient and therapist) and randomized

setting of study is Family hospital of army .In this study, 200 newly diagnosed COVID-19 hospitalized patients are selected based on inclusion and exclusion criteria . Patients are divided into two equal groups using the random function of Math lab software. beyond standard treatment based on the protocol recommended by the Ministry of Health for hospitalized patients, intervention and control groups will recieve medication and placebo one tablet every 6 hours for 5 days,respectively. The course of symptoms and clinical findings will be monitored daily by the project colleagues and the paraclinical findings will be evaluated before and after the 5-day intervention.

Inclusion criteria: 1. Non-pregnant and non-lactating women and men over 18 years with positive PCR for Covid 19 2. Existence of at least two of the following findings: RR>20, SO2<93%, GGO>10%, Presence of at least one underlying disease (DM, HTN, HF, COPD, asthma, Immunodeficiency) 3. Informed written consent to participate in the study Exclusion Criteria: 1. History of receiving the Covid 19 vaccine 2. Participation in another clinical trial

Medication group (n = 100) and placebo group (n = 100)

death ratio, need for ICU admision , duration of hospitalization, severity of shortness of breath, cough intensity, SO2 changes, RR changes, changes in inflammatory markers (ESR, CRP, LDH, WBC)

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.

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.

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Late 2021

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