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Background and purpose: Common cold is the most common viral and self-limited infection in children that is associated with high healthcare costs annual. Echinacea is commonly used for preventing and viral respiratory infections. The goal of this study was to assess Echinacea effect in improving the acute upper respiratory tract infection (URI) symptoms in children. Materials and methods: This clinical trial study performed on one hundred children aged 5 to 11 years with URI infection of pediatrics hospital in the Bandar-abbas. A complete history and physical examination were performed. Patients were assigned randomly in two groups and receive Echinacea and placebo. Echinacea group received the equivalent of 5 ml of Echinacea (root extract) per 12 hours during 10 days and control group received only analgesics and saline. Outcome measures were reducing duration and severity of symptoms and side effects at 10 days by parents or physical examination. The data were analyzed by SPSS version 16 software using descriptive, Chi-square test and T-test. Significant level was set as P<0.05. Results: In this double-blind study 100 patients enrolled, and mean age was 7.56±1.78 years. There was no significant difference in the mean duration fever, cough, rinorrhea and nasal congestion between Echinacea and control group. Any adverse effect was not observed in our study. Conclusion: The results of our study indicate Echinacea extract was not effective in duration symptoms of common cold in children but appears to be safe and without any allergic reaction. More well-designed randomized trial studies should be undertaken to assess the effects of Echinacea on treatment of children with common cold. [ABSTRACT FROM AUTHOR]