Study design and ethical approvement
MAY
This study was approved by the ethics committee of Isfahan University of Medical Sciences (IR.MUI.RESEARCH.REC.1399.834) on March 17th, 2021. All methods were performed in accordance with the relevant guidelines and regulations. It was a double-blind, randomized clinical trial conducted from May to June 2021. The study was also registered in the Iranian Registry of Clinical Trials (IRCT20100202003251N7) on 13/10/2021. Informed consent was obtained from patients involved in the study. The ethical guideline for this study was “General Ethical Guidance for Medical Research with Human Participants in the Islamic Republic of Iran.”