Evaluation of the effectiveness of complementary therapy with Portulaca oleracea capsule on the clinical symptoms of outpatients with COVID-19

Evaluation of the effectiveness of Portulaca Oleracea extract on the clinical COVID-19

Clinical trial with control group, with parallel groups, double-blind, randomized, block method, phase 3 on 140 patients. For randomization, the balanced block method is used using 4 blocks using SAS software.

Patients who have Covid 19 (RT-PCR confirmation) and have referred to the 16-hour treatment centers of Mashhad University of Medical Sciences and have the inclusion criteria, are included in the study. After obtaining informed consent, patients are randomly divided into 2 groups. The placebo group will receive the usual treatments and the placebo capsule and the intervention group, in addition to the usual treatments, will receive an oral capsule of portulaca oleracea extract at a dose of 600 mg (divided into a dose of 300 mg twice a day) for 2 weeks. Clinical and laboratory signs and symptoms will be studied, evaluated and compared before and after the intervention in both groups. The recovery time of symptoms including shortness of breath, anorexia, and oxygen saturation of the blood will be compared. The two groups are matched and equalized in terms of age, comorbidities, severity of Qovid involvement, and clinical symptoms.

Outpatients with PCR-approved Covid-19 with 90% oxygen have no underlying disease and are not pregnant or breastfeeding

In the intervention group, 600 mg of Portulaca Oleracea extract is given to patients along with common drugs. Control group (placebo) receive only common drugs with placebo.

Improvement of clinical symptoms (fever, cough and myalgia) and paraclinical (time of normalization of lymphopenia and CRP)

In order to allocate individuals in the two groups of 70 people studied, the blocking method will be used and for this purpose, among the given probabilities, four blocks have been randomly selected, which include: 1- ABBA- 2- AABB- 3- BABA-4-BBAA and each patient visited in one of the first or second groups will be entered in the blocks mentioned above, respectively. After completing the four blocks, the allocation of individuals in the study groups starts again from block one to complete the 140 samples required in the study.

This study is a clinical trial with two groups of control and intervention in which placebo is used. For blinding the study, drug form would be similar in two groups and the allocation of individuals is based on the block randomization method. The prescribing physician and the patient will not know the type of capsule that was the medication or the placebo.