Clinical study on Changyanning Granule in treatment of children with dyspepsia / 中草药

ABSTRACT

Objective: To evaluate the effects of Changyanning Granule for treating children with dyspepsia (damp heat syndrome of spleen and stomach). Methods: A randomized double-blind positive-controlled multi-center trial was used. Four hundred and eighty cases of children with dyspesia were randomly divided into experimental group and control group. The children in experimental group were given Changyanning Granule, and those in the control group were treated by Xiaoer Xishi Pian, then to evaluate the children with the disease in these two groups in improvement of clinical symptoms, total score of TCM syndrome efficacy, score of TCM individual symptome efficacy. Results: Two groups of 1-3 year old children in both the healing rate and significant efficiency and the total effective rate had no significant difference (P > 0.05). Two groups of 4-5 year old children in the healing rate and significant efficiency had no significant difference while the total effective rate was statistically significant (P<0.05). Two groups of 4-5 year old children in both the healing rate and significant efficiency and the total effective rate were statistically significant (P<0.05). Two groups of children in total score of TCM syndrome efficacy were statistically significant (P<0.05). The same group of score for TCM individual symptome efficacy after treatment, the difference was statistically significant (P<0.001), the improvement of abdominal fullness at the group of 1-3 year old, anorexia, body weight drowsiness, and short yellow urine symptoms at the group of 6-14 year old, meanwhile, were statistically significant (P<0.05), and the improvement of the experimental group was better than that of the control group. It was confirmed that Changyanning Granule in the treatment of children with dyspepsia is good safety through the analysis of safety indicators and adverse events. Conclusion: Changyanning Granule is a kind of Chinese medicine granule, which can be used for the treatment of children with dyspesia, spleen, and stomach damp heat syndrome by TCM syndrome differentiation. The therapeutic effect is reliable, and it is worth to be popularized in pediatrics.