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Study aim:
Determining the effect of CRSM-X7 as a herbal therapeutic supplement on the improvement of COVID-19 disease symptoms
Design:
Clinical trial with parallel control group, non-blinded, randomized, phase 3-2 on 200 patients. For randomization Block method was used.
Settings and conduct:
Using the formula for calculating the sample size, 200 patients referring to the medical centers of Baqiyatallah University of Medical Sciences will enter the study. 100 people in the intervention group receive a standard treatment regimen + herbal supplement, and 100 people in the comparison group receive only the same standard treatment regimen as the intervention group. There is no blinding in this study.
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
Diagnosis of COVID-19
Age 18-65
Having informed and written consent to participate in the study
Exclusion criteria:
Disagreement of the physician directly responsible for the patient
Pregnancy and breastfeeding
Allergies to the drug elements
Symptoms of gastrointestinal, liver or kidney disease
Incidence of drug interactions
Hypertension
Having heart failure
Do not take anticoagulants
Intervention groups:
The intervention group includes patients with COVID-19 disease who receive the standard treatment regimen intervention + herbal therapeutic supplement of CRSM-X7.
The comparison group includes patients with COVID-19 disease receiving standard dietary intervention.
Main outcome variables:
Duration of hospitalization
Fever
The need for ICU admission
Incidence of ARDS
Intubation requirements
Patient expire rate
O2 saturation
Body pain
Cough
Olfactory
Sense of taste
computed tomography scan