| Objective: To Xiaoer Suxieting particles as a control group, an objective assessment of Fengliao Changweikang mixture treatment of children with diarrhea (Damp-heat, improper diet)the clinical efficacy and safety.Methods: The randomized, double-blind (double dummy), parallel to the positive control drug in clinical trials, a total of 60 cases included in the standard of children, were randomly divided into treatment group and control group, all 30 cases. Treatment group Fengliao Changweikang mixture and the placebo control group given Xiaoer Suxieting particles and a placebo mixture , treatment for 3 days .To stool frequency, stool characteristics, abdominal pain, vomiting as the main effect of target, respectively, after treatment at 1 day, 2 days, 3 days, on two groups of children with symptoms of major inter-group comparison, the evaluation of the treatment groups at different differences in the efficacy phase. Of the total score before and after treatment to groups, group comparison, there is a comprehensive evaluation of the overall efficiency of the two groups, the cure rate. Record accurately the course of clinical trials of any symptoms of adverse reactions / adverse events and safety evaluation.Results: 1st day after treatment, 3 days, two groups of abdominal pain symptoms, the difference has statistical significance (P <0.05), The first 3 days after treatment, two groups of abdominal pain, vomiting symptoms, the difference has statistical significance (P <0.05).The first two days after treatment, the two groups in stool frequency, stool characteristics, abdominal pain, vomiting, rather, there was no significant difference (P> 0.05).After treatment, total symptom score were compared between groups, the difference was not statistically significant. The total effective rate in treatment group 96.7%, total effective rate of the control group 93.7%, compared the two groups was no significant difference (P> 0.05); the treatment group the cure rate is 36.7%, 13.0% for the control group, there is inter-group statistical difference between Significance of study (P <0.05). Two groups of drugs are a safety level.Conclusion: Fengliao Changweikang mixture treatment of children with diarrhea (Damp-heat, improper diet), can significantly improve the children with diarrhea, abdominal pain, vomiting, abdominal pain, particularly in regard to improvement in children, compared with the control group, effect of time earlier, more significant effect . The overall efficiency and there is no significant difference between the control group, but higher cure rate. Proved FengliaoChangweikang mixture are treatment of children with diarrhea (Damp-heat, improper diet) iseffective, safe drug. |