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

Gholam Reza Ghayour Razmgah; Seyed Mousal-Reza Hosseini; Homa Hajimehdipoor; Mehdi  Saberi Firoozi; Haniye Kashafroodi; Zeinab Ghahremani; Seid Mohammad Hasan Sadeghi; Rasool Choopani

doi:10.18502/tim.v6i4.8263

Gholam Reza Ghayour Razmgah Faculty of Iranian Traditional Medicine and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Seyed Mousal-Reza Hosseini Department of Gastroenterology and Hepatology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Homa Hajimehdipoor Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Mehdi Saberi Firoozi Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran
Haniye Kashafroodi Traditional Medicine and Materia Medica Research Center and Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Zeinab Ghahremani Medical-surgical Department, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran
Seid Mohammad Hasan Sadeghi Traditional Medicine and Materia Medica Research Center and Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Rasool Choopani Traditional Medicine and Materia Medica Research Center and Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/tim.v6i4.8263

Keywords: Functional constipation; Iranian polyherbal formulation; Ayarij-e-Faiqra; Rome III; Persian medicine

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.