Efficacy evaluation of an herbal compound “Fluherb” on clinical symptoms and paraclinical parameters in highly suspected COVID-19 patients: a controlled randomized clinical trial.

Evaluation of the effect of a herbal compound on patients with clinical and CT scan findings strongly suspected of COVID-19

This study is a randomized controlled clinical trial in which patients will be simply selected from hospitalized patients with corona. Individuals with eligibility criteria will be randomly divided into two groups of intervention and control, and 30 patients will be enrolled in each group. The study is three-blinded and the patient, the nurse giving the medication, the data collector, and the data analyzer are not aware of the type of assignment.

This study will be carried out at Imam Reza Hospital, one of the hospitals affiliated to Mashhad University of Medical Sciences. This hospital has been assigned for corona patients. This research will be carried out in March and April of 2020.

Inclusion criteria: Hospitalized patients who are suspected to COVID- 19 based on clinical symptoms and computed tomography findings; Clinically classified as moderate and severe; No organ damage; age under 70 years; They are stable in cardiovascular status. Non-inclusion criteria: Pregnant and lactating women; End stage patients

This study consists of two groups. Intervention group will receive a herbal compound so-called Fluherb containing extracts of purslane, Plantain, hyssop, licorice and turmeric prepared in suspension dosage form. The control group received a placebo syrup. The intervention period is five days and the drug will be administered orally in three divided doses. Both groups receive all current treatments and will be matched according to clinical status.

Changes in clinical conditions and severity of disease

The expiration date of the study was changed due to problems in patient selection and hospital ward restrictions. The elderberry fruit available in the market is not of good quality and in the initial evaluation it seemed that the cyanide level is higher than the standard, so the leaves of the hyssop were replaced and instead of hydroethonolic extract, a more safe aqueous extract was used. In addition, due to the low quality of the plantain leaves in the market, plantain seed were used instead of its leaves.

Balanced block randomization

In this study, patients will be informed by consent form that they would either be in the intervention group or the control group, but they won't be aware of the type of medication. Nurses who supply the drug are also unaware of its content because the appearance, taste, color, and prescription of the drug are similar, but the code on the drug will be different. The written codes on the drugs are random and only the pharmacist's partner is aware of the drug type and the inserted code on it. The patient data collector and the project statistical partner are also unaware of the type of intervention. As the control group uses placebo, which is similar in appearance, taste, color, and prescription, patients will be unaware of the type of drug being administered.