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Study aim:
Preparation of two oral herbal remedies including decoction and capsule and evaluation of their efficacy in patients with COVID-19 via a randomized clinical trial.
Design:
Randomized Concurrent Controlled Trial
Settings and conduct:
68 patients are selected based on national guidelines for diagnosis and treatment of COVID-19 requiring hospitalization and drug treatment. Thirty-four patients receive routine treatment, and 34 receive herbal remedies (decoction every 8 hours and capsules every twelve hours) plus routine treatment for 2 weeks.To randomly assign the patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number.
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
1. Patients with one or more of the following symptoms in addition to acute respiratory disease (ARI):
• RR> 30
• PO2 <93%
• Pulmonary infiltration in chest x-ray
2. Age range of 18 to 75 years in both genders
3. Patient not intubated.
4. Lack of any serious concomitant disease of the heart, brain, or lungs, metabolic disorders, and etc.
Exclusion criteria:
1. Pregnancy and lactation
2. Any history of allergy to any of the herbal product components
3. Inability to take a drug per-oral
4. Need for intubation
5. Any condition that precludes continuance of medical intervention based on the judgment of a physician.
Intervention groups:
34 patients receive routine interventions according to the instructions of the Ministry of Health and 34 patients receive herbal treatment (decoction every 8 hours and capsule every 12 hours) with routine interventions based on the instructions of the Ministry of Health for 2 weeks.
Main outcome variables:
The rate of radiologic improvement in chest x-ray or CT scan based on expert evaluation