NCT04146103

A Pumpkin Seed, Isoflavonoid and Cranberry Mix in LUTS/BPH

Prospective Multicenter Open-label One Arm Trial Investigating a Pumpkin Seed, Isoflavonoid and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The patients will be evaluated based on the severity of LUTS, urological quality of life, and erectile function.

Detailed description

This is a single-arm prospective open-label trial investigating a combination of pumpkin seed, isoflavonoid and cranberry mix in improving LUTS, urological quality of life, and erectile function in BPH patients. The compound will be administered orally two tablets daily for 3 months. Recruited patients will be seen at 3 visits: initial visit (visit 1), 1-month visit (visit 2) and 3-month visit (visit 3) and their data will be collected in a dedicated case report form.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Novex	Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-01-31
• Completion: 2019-03-31
• First posted: 2019-10-31
• Last updated: 2019-10-31

Locations

1 site across 1 country: Lebanon