Evaluating the efficacy of herbal capsule in COVID-19 patients in a clinical trial

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.

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

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.

Temperature; Respiratory rate; cough, dyspnea, O2 saturation, WBC count

Block randomization method is used in this study. The treatment assignment is in a 1:1 ratio, and there are two groups, then, the block size is chosen 4. Possible balanced combinations are calculated with 2 subjects in control and 2 subjects in the intervention group (Six possibilities). In each 4 block size, two patients will be assigned to the intervention (capsule) group and two patients will be assigned to the control group. To allocate all participants in the two groups, the blocks are randomly selected.

All results will be shared with identified individuals

Start the access period from 6 months after printing results

Academic researchers can access data

For use in review articles, and modeling can be used in other studies.

for data accessing, send an email to mseteyeshmail@gmail.com. Or call 09133950546

It will be done through coordination with the executor or the vice chancellor for research of the university and after the identification of the applicant.