Zobeiri Mehdi1, Parvizi Fatemeh2, Rahimi Roja3, Heydarpour Fatemeh4, Sheikhan Hamid Reza3, Navabi Jafar5, Farzaei Mohammad Hosein6. 1. Internal Medicine Department, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah 6734667149, Iran. 2. Pharmaceutical Sciences Research Center, Kermanshah University of Medical Sciences, Kermanshah 6734667149, Iran. 3. Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran 1113913661, Iran. 4. Medical Biology Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah 6734667149, Iran. 5. Clinical Research Development Center, Imam Khomeini Hospital and Department of Internal Medicine, Kermanshah University of Medical Sciences, Kermanshah 6734667149, Iran. 6. Medical Technology Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah 6734667149, Iran.
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.
RCT Entities:
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.