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OpenTrials
Completed

NCT Number: NCT04146103

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Elie El Helou

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novex

Drug

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

Primary outcomes

  1. IPSS

    Time frame: At 1 and 3 months visits

    Change in IPSS

Secondary outcomes

  1. IPSS subscores

    Time frame: At 1 and 3 months visits

    Change in IPSS subscores (voiding, filling, nocturia)

  2. uQoL

    Time frame: At 1 and 3 months visits

    Change in uQoL

  3. IIEF-5

    Time frame: At 1 and 3 months visits

    Change in IIEF-5

  4. Rate of ejaculatory dysfunction and orthostatic hypotension

    Time frame: At 1 and 3 months visits

    Rate

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2019
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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