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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Novex
Sponsored by
Saint-Joseph University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Elie El Helou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm 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.

Outcomes

Primary Outcome Measures

IPSS
Change in IPSS

Secondary Outcome Measures

IPSS subscores
Change in IPSS subscores (voiding, filling, nocturia)
uQoL
Change in uQoL
IIEF-5
Change in IIEF-5
Rate of ejaculatory dysfunction and orthostatic hypotension
Rate

Full Information

First Posted
October 28, 2019
Last Updated
October 28, 2019
Sponsor
Saint-Joseph University
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1. Study Identification

Unique Protocol Identification Number
NCT04146103
Brief Title
A Pumpkin Seed, Isoflavonoid and Cranberry Mix in LUTS/BPH
Official Title
Prospective Multicenter Open-label One Arm Trial Investigating a Pumpkin Seed, Isoflavonoid and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint-Joseph University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Novex
Intervention Description
Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.
Primary Outcome Measure Information:
Title
IPSS
Description
Change in IPSS
Time Frame
At 1 and 3 months visits
Secondary Outcome Measure Information:
Title
IPSS subscores
Description
Change in IPSS subscores (voiding, filling, nocturia)
Time Frame
At 1 and 3 months visits
Title
uQoL
Description
Change in uQoL
Time Frame
At 1 and 3 months visits
Title
IIEF-5
Description
Change in IIEF-5
Time Frame
At 1 and 3 months visits
Title
Rate of ejaculatory dysfunction and orthostatic hypotension
Description
Rate
Time Frame
At 1 and 3 months visits

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Elie El Helou
City
Beirut
ZIP/Postal Code
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22268969
Citation
Wong WC, Wong EL, Li H, You JH, Ho S, Woo J, Hui E. Isoflavones in treating watchful waiting benign prostate hyperplasia: a double-blinded, randomized controlled trial. J Altern Complement Med. 2012 Jan;18(1):54-60. doi: 10.1089/acm.2010.0077.
Results Reference
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PubMed Identifier
25613154
Citation
Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
Results Reference
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PubMed Identifier
11306400
Citation
Blanker MH, Bosch JL, Groeneveld FP, Bohnen AM, Prins A, Thomas S, Hop WC. Erectile and ejaculatory dysfunction in a community-based sample of men 50 to 78 years old: prevalence, concern, and relation to sexual activity. Urology. 2001 Apr;57(4):763-8. doi: 10.1016/s0090-4295(00)01091-8.
Results Reference
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PubMed Identifier
17265598
Citation
Kaminetsky J. Comorbid LUTS and erectile dysfunction: optimizing their management. Curr Med Res Opin. 2006 Dec;22(12):2497-506. doi: 10.1185/030079906x154141.
Results Reference
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PubMed Identifier
16469026
Citation
Kaplan SA, DE Rose AF, Kirby RS, O'leary MP, McVary KT. Beneficial effects of extended-release doxazosin and doxazosin standard on sexual health. BJU Int. 2006 Mar;97(3):559-66. doi: 10.1111/j.1464-410X.2005.05959.x.
Results Reference
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PubMed Identifier
27377091
Citation
Damiano R, Cai T, Fornara P, Franzese CA, Leonardi R, Mirone V. The role of Cucurbita pepo in the management of patients affected by lower urinary tract symptoms due to benign prostatic hyperplasia: A narrative review. Arch Ital Urol Androl. 2016 Jul 4;88(2):136-43. doi: 10.4081/aiua.2016.2.136.
Results Reference
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PubMed Identifier
20098586
Citation
Hong H, Kim CS, Maeng S. Effects of pumpkin seed oil and saw palmetto oil in Korean men with symptomatic benign prostatic hyperplasia. Nutr Res Pract. 2009 Winter;3(4):323-7. doi: 10.4162/nrp.2009.3.4.323. Epub 2009 Dec 31.
Results Reference
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PubMed Identifier
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Citation
Vahlensieck W, Theurer C, Pfitzer E, Patz B, Banik N, Engelmann U. Effects of pumpkin seed in men with lower urinary tract symptoms due to benign prostatic hyperplasia in the one-year, randomized, placebo-controlled GRANU study. Urol Int. 2015;94(3):286-95. doi: 10.1159/000362903. Epub 2014 Sep 5.
Results Reference
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PubMed Identifier
19042940
Citation
McMurdo ME, Argo I, Phillips G, Daly F, Davey P. Cranberry or trimethoprim for the prevention of recurrent urinary tract infections? A randomized controlled trial in older women. J Antimicrob Chemother. 2009 Feb;63(2):389-95. doi: 10.1093/jac/dkn489. Epub 2008 Nov 28.
Results Reference
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PubMed Identifier
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Citation
Vidlar A, Student V Jr, Vostalova J, Fromentin E, Roller M, Simanek V, Student V. Cranberry fruit powder (Flowens) improves lower urinary tract symptoms in men: a double-blind, randomized, placebo-controlled study. World J Urol. 2016 Mar;34(3):419-24. doi: 10.1007/s00345-015-1611-7. Epub 2015 Jun 7.
Results Reference
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A Pumpkin Seed, Isoflavonoid and Cranberry Mix in LUTS/BPH

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