A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia.

ABSTRACT:

Background

Benign Prostrate Hyperplasia (BPH) is a progressive disease of ageing men that may be associated with enlargement of the prostate and lower urinary tract symptoms (LUTS). Herbal/Nutraceutical formulations in addition to standard of care (SOC) could alleviate the symptoms, and thus improve the quality of life of patients.

Objectives

To evaluate safety & efficacy of nutraceutical tablet as an adjuvant with SOC.

Materials and methods

This was a prospective, randomized two-arm study aimed to assess the safety and efficacy of Herbal/Nutraceutical Formulation (IP) + SOC versus only SOC, in BPH patients. The primary efficacy endpoint was the change in international prostate symptom score (IPSS) within and between two arms. The safety was evaluated in terms of adve

SUBMITTER: Patankar SB 

PROVIDER: S-EPMC11539405 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature