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

Saint-Joseph University

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Novex

Study type: Interventional

Funder types: Other

Identifiers

NCT04146103

AJ13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild to moderate LUTS due to BPH for at least 6 months at the initial visit
• no previous therapy or are still symptomatic despite the current use of alpha-blockers

Exclusion criteria

• International Prostate Symptom Score (IPSS) > 19
• Prostate cancer
• Urethral stenosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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163 participants in 1 patient group

Experimental arm

Experimental group

Description:

Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally, for 3 months.

Treatment:

Drug: Novex