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.