Efficacy and safety of Hemoheal cream in patients with hemorrhoids: a randomized double-blind placebo controlled clinical trial

OBJECTIVE: To evaluate the efficacy and safety of Hemoheal cream, an anti-hemorrhoid herbal preparation, (inspired by Persian medicine literatures in a double-blind, randomized placebo-controlled trial. METHODS: Hemoheal cream consists of aqueous extract of Allium ampeloprasum L., Commiphora mukul (Hook. Ex Stocks) Engl and the oil of Sesamum indicum L. Fifty-two patients with symptomatic hemorrhoids were randomized to receive hemoheal cream or placebo for 3 weeks. The patients were evaluated before and after the intervention in terms of the severity of anal irritation, bleeding, anal itching, pain, defecation discomfort and swelling sense, and overall subjective improvement (%), as well as any reported adverse events. RESULTS: The results showed that after 3 weeks of treatment, distribution of anal irritation, bleeding, pain as well as swelling sense were significantly different (P < 0.05), while the analysis showed no significant differences between two groups for anal itching and defecation discomfort (P > 0.05). Furthermore, a significant difference was observed between the overall subjective improvement of Hemoheal cream and placebo groups (P = 0.012). One patient in the treatment group complained of rashes on the application site. CONCLUSION: The present study showed a positive effect of Hemoheal cream in improving clinical signs and symptoms in patients with hemorrhoids. (C) 2021 JTCM. All rights reserved.