Trial design
RECRUITMENT
This original prospective 1-week double-blinded parallel randomized controlled trial is a part of a whole program, in which a total of 54 patients were randomly assigned into intervention or placebo arms. Recruitment of participants was carried out between June 2018 and August 2019. The whole protocol was approved by the Research Ethics Committee of Mashhad University of Medical Sciences (registration code: IR.MUMS.fm.REC.1396.671) and was registered in the Iranian Registry of Clinical Trials (registration code: IRCT 20151108024938N2).