A single-center non-blinded randomized clinical trial to assess the safety and effectiveness of PhR160 spray the treatment of COVID-19 pneumonia

Abstract

COVID-19 is an emerging pandemic that caused a very widespread infection with more than 1000000 cases in Iran within a year. The main cause of mortality among patients with COVID-19 is pulmonary failure. In Iranian Traditional Medicine, essences have been used for curing pulmonary diseases. Pinen-Hydeonoplacton-Ribonucleic acid (PHR) is an inhaler spray made of seven different plants, which all are used by humans, have desirable pharmacological features for treating pulmonary symptoms of COVID-19 patients. This study was conducted to assess the safety and effectiveness of PHR160 spray in improving pulmonary symptoms of COVID-19 patients. This was a single-center, non-blinded randomized clinical trial with two parallel groups in two different wards of Baqiyatallah hospital, Tehran, Iran. Participants were 51 male patients, diagnosed with COVID-19 pneumonia, divided into 2 groups of 32 in the intervention group and 31 in the control group. The intervention group received 5 days of PHR160 spray, 10 puffs each day, 300 micrograms in each puff in addition to the routine treatment. Oxygen saturation was measured by a pulse oximeter, every 6 hours and recorded daily This study showed that the intervention increased significantly the arterial oxygen saturation percentage in COVID-19 patients. In addition, it decreases hospitalization duration, dyspnea score and cough score significantly in the patients. The statistical modeling test, with adjusting the age and respiratory rate for baseline and 4 days of the intervention, shows that the oxygen saturation percentage mean was significantly more in the intervention group by 5.14 units (p<0.001).