ABSTRACT
BACKGROUND: Since December 2019, the outbreak of coronavirus pneumonia was observed in China and quickly propagate in all of the world. Nowadays, many trials are underway on this disease in which the efficacy of various therapeutic remedies including chemical or natural agents as well as different non-pharmacological methods such as acupuncture are evaluated. This study aims at investigating the effect of M. communis fruit for treatment of COVID-19 disease. METHODS: We are performing an open-label randomized controlled trial on outpatients clinically suspected to COVID-19 disease in the age range of 18-65 years old with mild to moderate symptoms and without respiratory distress. Patients in both groups (M. communis and control) receive conventional therapy, but those in M. communis group get M. communis preparation in addition to conventional therapy. Intervention will continue for 5 days and the study outcomes including clinical status as well as mortality rate and adverse effects will be measured up to 14 days. DISCUSSION: The protocol describes the design of an ongoing randomized controlled trial to establish the evidence for the usage of water extract of M. communis fruit in clinically suspected COVID-19 disease and identify any safety concerns. TRIAL REGISTRATION: The trial has been registered at the Iranian Registry of Clinical Trials website under the code IRCT20180923041093N3 on March 28th, 2020 ( https://www.irct.ir/trial/46721 ). The results will be disseminated through manuscript publications and presentations to scientific meetings.