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

October 28, 2019 updated by: Saint-Joseph University

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beirut, Lebanon, Beirut
        • Elie El Helou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
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.
Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPSS
Time Frame: At 1 and 3 months visits
Change in IPSS
At 1 and 3 months visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPSS subscores
Time Frame: At 1 and 3 months visits
Change in IPSS subscores (voiding, filling, nocturia)
At 1 and 3 months visits
uQoL
Time Frame: At 1 and 3 months visits
Change in uQoL
At 1 and 3 months visits
IIEF-5
Time Frame: At 1 and 3 months visits
Change in IIEF-5
At 1 and 3 months visits
Rate of ejaculatory dysfunction and orthostatic hypotension
Time Frame: At 1 and 3 months visits
Rate
At 1 and 3 months visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 31, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • AJ13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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