Clinical Research On Xiao’er Fuxiekang Granule For Infantile Diarrhea Of Damp-heat Type

Objective:To evaluate the clinical efficacy and safety of Xiao’er Fuxiekang Granule in the treatment of infantile diarrhea of damp-heat type.Methods:According to the inclusion criteria,96children suffering from infantile diarrhea of damp-heat type were recruited and randomized into treatment group (n=72) and control group (n=24).The treatment group was given with Xiao’er Fuxiekang Granule and the dosage was computed according to age, while the control group took with placebo. By means of evaluation of the TCM syndrome score and effective rate, validate the clinical efficacy and safety of Xiao’er Fuxiekang Granule.Results:70cases of the treatment group and23cases of the control group completed the whole observation. There was no significant difference in ages gender and disease course between the two groups(p>0.05). while, In the70cases treatment group,28cases had remarkable therapeutic effect,30cases had effect and12had no effect, total effective rate was82.85%. In the control group,5patients had remarkable effect,7had effective effect and11had no effect, total effective rate was52.17%. There was significant difference in comprehensive therapeutic effect between the two groups (p<0.05). There was significant difference in TCM syndrome relieving efficacy between the two groups (p<0.05), the treatment group was superior to the control group. In the70cases of treatment group,36cases were cured,20patients had apparent effect,12had effect and2had no effect, total effective rate was97.14%. In the23cases of control group,8cases were cured,7patients had apparent effect,4had effective effect and4had no effect, total effective rate was 82.61%.Safety evaluation:In the trial,2cases had appeared adverse reaction related to the test drug. Incidence rate of adverse events was within normal range. The two groups had no serious adverse events and security level evaluation was level2.Conclusions:The curative effect of Xiao’er Fuxiekang Granule on infantile diarrhea of damp-heat type was effective and safe.