Abstract: OBJECTIVE: To assess the efficacy and safety of Reduning injection for fever, rash, and ulcers in children with mild hand, foot, and mouth disease(HFMD). METHODS: A stratified-block randomized, double-blind, parallel-controlled, and multicenter clinical trial was conducted with 360 patients in five hospitals across China: Quanzhou Children's Hospital, Shijiazhuang No. 5 Hospital, Shanghai Public Health Centre, Hunan Provincial Children's Hospital, and Kaifeng Children's Hospital. Patients were randomized into three groups with 120 in each. Group A was treated with Western Medicine, group B with Reduning injection, a Chinese herbal medicine, and group C with both Reduning injection and Western Medicine. Results were compared for treatment efficacy and safety on HFMD. The clinical outcomes were observed as follows: fever and onset time of antifebrile effect(time to bring the body temperature down ≥0.5℃ after medication); cumulative time for fever recovery(body temperature recovering to normal and lasting more than 24 h without medication); cumulative time for rash disappearance(without new rashes or ulcers appearing and the original ones fading away); and cumulative time for mouth ulcer disappearance. RESULTS: For the onset time of the antifebrile effect, there was no statistical difference between groups A and B(P>0.05) and groups B and C(P> 0.05). However, there was a statistical difference between groups A and C(P0.05). There were statistical differences between groups A and C, and groups B and C(P0.05). CONCLUSION: Reduning injection with Western Medicine for symptomatic treatment is most effective for mild HFMD. No adverse reactions were observed.

Key words: Hand,foot and mouth disease, Symptomatic therapy, Randomized controlled trial, Treatment outcome, Reduning injection