The Effect of An Aloe-Based Polyherbal Formulation in Adults with Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled, Six-Months Clinical Follow-up Trial

Abstract

The most common functional gastrointestinal problem in the world is functional constipation. "Ayarij-e-Faiqra (AF)" is a polyherbal formula that has been recommended by Persian Medicine as an efficent purgative agent . The purpose of this study was to evaluate the effect of AF on functional constipation using a double-blind, placebo-controlled clinical trial. According to the Rome III classification, 79 adults with functional constipation were included in this trial. The diagnostic criteria were according to the Rome III classification. Patients with constipation symptoms who referred to the traditional medicine clinic of Shahid Beheshti University of Medical Sciences from April 2014 to September 2016 were randomly allocated to the AF and placebo groups. The AF and placebo groups received AF and placebo for three months, respectively and followed up for another three months. During the study, the treatment efficacy was assessed by a questionnaire. AF treatment significantly decreased most of the symptoms by 84% at the end of the first month (p < 0.05) and by 90% at the end of the third month in comparison to placbo group (p < 0.001). However, three months after the end of the intervention, the frequency of constipation symptoms in both groups was not statistically significant. Based on the satisfaction questionnaire, the treatment satisfaction score during the intervention was increased to 9 in the AF group, but no significant difference was found between the two groups three months after the intervention (p > 0.005). Although AF could be beneficial for treating functional constipation without significant side effects, changing patients’ lifestyles has great importance in this process.