Journal of Traditional Chinese Medicine ›› 2021, Vol. 41 ›› Issue (2): 301-307.DOI: 10.19852/j.cnki.jtcm.20210224.001

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

Mehdi Zobeiri;Fatemeh Parvizi;Roja Rahimi;Fatemeh Heydarpour;Hamid Reza Sheikhan;Jafar Navabi;Mohammad Hosein Farzaei;   

  1. [Zobeiri, Mehdi] Kermanshah Univ Med Sci, Imam Reza Hosp, Internal Med Dept, Kermanshah 6734667149, Iran; [Parvizi, Fatemeh] Kermanshah Univ Med Sci, Pharmaceut Sci Res Ctr, Kermanshah 6734667149, Iran; [Rahimi, Roja; Sheikhan, Hamid Reza] Univ Tehran Med Sci, Dept Tradit Pharm, Sch Persian Med, Tehran 1113913661, Iran; [Heydarpour, Fatemeh] Kermanshah Univ Med Sci, Med Biol Res Ctr, Hlth Technol Inst, Kermanshah 6734667149, Iran; [Navabi, Jafar] Kermanshah Univ Med Sci, Imam Khomeini Hosp, Clin Res Dev Ctr, Kermanshah 6734667149, Iran; [Navabi, Jafar] Kermanshah Univ Med Sci, Dept Internal Med, Kermanshah 6734667149, Iran; [Farzaei, Mohammad Hosein] Kermanshah Univ Med Sci, Med Technol Res Ctr, Hlth Technol Inst, Kermanshah 6734667149, Iran
  • Online:2021-04-15 Published:2021-04-15
  • Supported by:
    Supported by Kermanshah University of Medical Sciences(grant No. 96455)

Abstract: 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.

Key words: Hemorrhoids;;Allium;;Commiphora;;Sesamum;;Medicine,Iranain traditional;;Controlled clinical trial