The Efficacy of a Persian Medicine Formulation on Adult Functional Constipation: A Double-blinded Clinical Trial

Abstract

Background: Constipation is a common disorder, and its management imposes a significant health burden. Integration of complementary and alternative medicine into the current health system may result in beneficial outcomes. Objective: This study aimed to evaluate the efficacy and safety of a Persian medicine preparation (Jalinous capsule) on functional constipation. Jalinous capsule is a combination of rose (Rosa damascena), mastic (Pistacia lentiscus), Aloe vera (Aloe barbadensis), and turpeth (Ipomoea turpethum). Methods: From January to December 2019, 126 patients aged 18 - 50 with functional constipation according to Rome IV criteria referred to Imam Khomeini hospital's gastrointestinal disease clinic were blindly randomized into "Jalinous" capsule group and placebo group for four weeks. Both groups received psyllium indeed. The patients were followed up at weeks two and four of the treatment and four weeks after the termination of the intervention. Results: Although the frequency of defecation, percentage of incomplete defecation and evacuation, straining during defecation, using manual maneuver to facilitate evacuation and defecation time showed significant improvement in both groups (P < 0.001), improvements in the intervention group were significantly more than in control group (P < 0.001). At the end of the second and fourth weeks of taking the drug and four weeks after stopping the drugs, the patients in the intervention group reported less frequent hard stool form in comparison to the patients in the control group (P < 0.001). Their overall self-reported improvement in symptoms after the treatment was significantly higher than the patients in the placebo group (P < 0.001). Adverse effects were not serious and mostly were transient. Conclusion: "Jalinous" capsule is an effective and safe treatment for functional constipation in adults, but more studies are needed to make confident conclusions.