Evaluating the efficacy of herbal products (capsule) in COVID-19 patients in a clinical trial
A clinical trial with a control group, with parallel, randomized groups, phase 3 on 100 patients. For randomization, a table of random numbers based on Random Allocation software was used. Blinding was not possible.
Settings and conduct:
100 patients will be selected according to the national guidelines for diagnosis and treatment of COVID-19 disease that require hospitalization, and 50 patients receive routine treatment and 50 patients receive herbal treatment (capsule every 12 hours) along with routine treatment for 1 week. With the simple randomization method and based on the table of random numbers, it will be divided into two groups and one
Participants/Inclusion and exclusion criteria:
Inclusion criteria: Patients of both sexes in the age range of 18 to 75 years, who require hospitalization according to the national guidelines for diagnosis and treatment of COVID-19, and have completed an informed consent form to enter the study.
Exclusion criteria: pregnancy and lactation, the presence of any history of allergy to any of the components of the herbal product, the patient's inability to take oral form, the patient's involvement in any serious concomitant underlying diseases, including hypertension, heart disease, lung disease, Brain disease, and diabetes.
In the control group, 50 patients received routine supportive interventions and standard COVID-19 treatment regimen based on the Ministry of Health protocol, including hydroxychloroquine at a dose of 200 mg twice daily. In the intervention group, 50 patients receive a capsule containing herbal products every 12 hours for 1-week in addition to standard COVID-19 treatment based on the Ministry of Health protocol.
Main outcome variables:
Temperature; Respiratory rate; cough, dyspnea, O2 saturation, WBC count