Clinical Research On Xiao’er Biantong Granule For Functional Constipation Of Dyspepsia Type

Objective:To evaluate the clinical efficacy and safety of Xiao’er Biantong Granule in the treatment o f functional co nstip ation o f dyspepsia typ e.Methods:According to the inclusion criteria,64children suffering from infantile diarrhea of dyspepsia type were recruited and randomized into treatment group (n=48) and control group (n=16).The treatment group was given with Xiao’er Biantong 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 Biantong Granule.Results:47cases of the treatment group and15cases of the control group completed the whole observation. There was no significant difference in ages gender and disease course between the two group s(p>0.05). while, In the47cases treatment group,21cases were cured,17cases had remarkable therapeutic effect,5cases had effect and4had no effect, total effective rate was91.49%. In the control group,1patients had remarkable effect,4had effective effect and10had no effect, total effective rate was33.33%. 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 the47cases of treatment group,16cases were cured,18patients had apparent effect,8had effect and5had no effect, total effective rate was89.36%. In the15cases of control group,1cases were cured,1patient had apparent effect,3had effective effect and10had no effect, total effective rate was33.33%.Safety evaluation:In the trial,lcase 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.Conclusion:The curative effect of Xiao’er Biantong Granule on functional constipation of dyspepsia type was effective and safe.