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Submitted: 03 Mar 2025
Revision: 23 Jun 2025
Accepted: 21 Jul 2025
ePublished: 11 Oct 2025
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Pharm Sci. 2025;31(4): 497-505.
doi: 10.34172/PS.025.42320
  Abstract View: 48
  PDF Download: 58

Research Article

Evaluation of the Effect of the oral Formulation Prepared from the Extract of Pomegranate Peel for the Treatment of Benign Prostate Hyperplasia: A Triple-Blind Randomized Clinical Trial

Mehrshad Ebrahimpour 1 ORCID logo, Javad Darabi Mahboub 1, Melika Ahmadi 1, Samin Ghorbani Moghadam 1, Mohammad Reza Darabi Mahboub 2, Alireza Akhavan Rezayat 2, Sepideh Elyasi 3* ORCID logo

1 School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
2 Department of Urology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
3 Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
*Corresponding Author: Sepideh Elyasi, Email: elyasis@mums.ac.ir

Abstract

Background: Benign prostatic hyperplasia (BPH) is a common condition affecting older men, primarily driven by hormonal imbalances and inflammation. This study aimed to investigate the effects of pomegranate peel extract, rich in anti-inflammatory and antioxidant polyphenolic compounds like anthocyanins and tannins, on BPH symptoms compared to a placebo.

Methods: Forty patients aged 50-80 with BPH from Ghaem Hospital in Mashhad were randomly assigned to either the treatment or control group. The treatment group (20 patients) received 250 mg of pomegranate peel extract capsules three times daily alongside tamsulosin 0.4 mg nightly for four months. In the control group (20 patients) lactose capsules was prescribed as a placebo with the same dosing. The severity of lower urinary symptoms was assessed using the International Prostate Symptom Score (IPSS), along with prostate size via ultrasound at baseline and after 2 and 4 months and prostate-specific antigen (PSA) serum levels just at the beginning and end of study.

Results: Baseline prostate sizes, PSA serum level and IPSS scores were comparable between two groups (P>0.05). At the 4-month follow-up, the pomegranate peel extract group demonstrated significantly lower symptom scores compared to the placebo group (P=0.004), although no meaningful difference was observed after 2 months (P=0.067). Moreover, the prostate size did not change meaningfully after 2 and 4 months in comparison with the placebo group (P=0.226 & 0.355) and also PSA serum level was not significantly lower in pomegranate group after 4 months of therapy (P=206).

Conclusion: As indicated by the IPSS, a daily regimen of 250 mg of pomegranate peel extract for four months effectively alleviated BPH symptoms. This suggests its potential as a treatment option for BPH, warranting further human studies to explore its efficacy.


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