A Double Blind Randomized Comparative Clinical Trial of Herbal Preparation (Laxoherb Kid SyrupR) with Dietary Regulation and Toilet Training for the Management of Functional Constipation in Children

Constipation in children is defined as a delay or difficulty in defecation resent for two or more weeks. According to Ayurveda “Vibandha” is among the commonest clinical conditions in children with difficulty defecating, hard stools, and infrequent bowel movements. The current trial is proposed to study the effect of Laxoherb Kid Syrup by using specific parameters for Vibandha w.s.r. to functional constipation. The objective of the present study is to evaluate the effect of Laxoherb Kid Syrup in the management of Vibandha (Functional constipation) in children. The children of either gender between the age group of 02-16 years fulfilling the diagnostic criteria of functional constipation, whose parents are willing to give consent, will be registered for the clinical study. The test drug, Laxoherb Kid Syrup will be given in two groups (a) age 2-8 yrs. at the dose of 5 ml twice daily orally for 15 days and (b) age 9-16 yrs. at the dose of 10 ml thrice daily orally for 15 days. The placebo will be given at the same dose without active ingredients. The assessment will be done following the ROME III criteria and Bristol criteria for functional constipation depending upon the age of the child at day 15. The safety blood profile will also be checked. The data collected before and after the intervention within the group and between the groups will be recorded and evaluated using non-parametric statistical methods (Wilcoxon signed rank test, Mann Whitney test and Chi-square test which will be applicable.