OBJECTIVE:To evaluate the efficacy and safety of Hemoheal cream,an anti-hemorrhoid herbal prepa-ration,(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 Sesa-mum indicum L.Fifty-two patients with symptom-atic hemorrhoids were randomized to receive he-moheal 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 swell-ing 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 dif-ferent(P<0.05),while the analysis showed no sig-nificant differences between two groups for anal itching and defecation discomfort(P>0.05).Fur-thermore,a significant difference was observed be-tween the overall subjective improvement of He-moheal cream and placebo groups(P=0.012).One patient in the treatment group complained of rash-es on the application site.CONCLUSION:The present study showed a posi-tive effect of Hemoheal cream in improving clinical signs and symptoms in patients with hemorrhoids.