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 \textless 0.05), while the analysis showed no significant differences between two groups for anal itching and defecation discomfort (P \textgreater 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.