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.