The effects of a diet based on Iranian medicine on clinical outcomes and laboratory biomarkers of patients with COVID-19

The effects of a diet based on Iranian medicine on clinical outcomes and laboratory biomarkers of patients with COVID-19 admitted to hospital

Clinical trial with control group, with parallel intervention group, and randomized

Setting of study is Emam Reza hospital of army .In this study, 160 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 groups will receive a diet based on Iranian medicine and control group will receive hospital standard diet for 5 days. 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% 3. Absence of underlying disease 4.Informed written consent to participate in the study Exclusion Criteria: 1.Participation in another clinical trial 2. when allergies or any complications happen

Intervention group: receive a diet based on Iranian medicine (80 person) Control group: receive the hospital diet (low salt, low fat) (80 person) both group receive COVID-19 standard treatment (Remdesivir, prophylactic anticoagulant, and low dose corticosteroids)

need for ICU admission , 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, 180 people are randomly divided into two groups of 80 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 160, which represent 160 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 food package. The food package is filled based on the extracted file by a person who is not involved in the research process.