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
1 other identifier
interventional
163
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedFirst Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedOctober 31, 2019
October 1, 2019
10 months
October 28, 2019
October 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
IPSS
Change in IPSS
At 1 and 3 months visits
Secondary Outcomes (4)
IPSS subscores
At 1 and 3 months visits
uQoL
At 1 and 3 months visits
IIEF-5
At 1 and 3 months visits
Rate of ejaculatory dysfunction and orthostatic hypotension
At 1 and 3 months visits
Study Arms (1)
Experimental arm
EXPERIMENTALNovex® 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.
Interventions
Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- International Prostate Symptom Score (IPSS) \> 19
- Prostate cancer
- Urethral stenosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Elie El Helou
Beirut, Beirut, Lebanon
Related Publications (10)
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.
PMID: 22268969BACKGROUNDGratzke 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.
PMID: 25613154BACKGROUNDBlanker 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.
PMID: 11306400BACKGROUNDKaminetsky J. Comorbid LUTS and erectile dysfunction: optimizing their management. Curr Med Res Opin. 2006 Dec;22(12):2497-506. doi: 10.1185/030079906x154141.
PMID: 17265598BACKGROUNDKaplan 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.
PMID: 16469026BACKGROUNDDamiano 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.
PMID: 27377091BACKGROUNDHong 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.
PMID: 20098586BACKGROUNDVahlensieck 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.
PMID: 25196580BACKGROUNDMcMurdo 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.
PMID: 19042940BACKGROUNDVidlar 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.
PMID: 26049866RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
October 31, 2019
Study Start
April 1, 2018
Primary Completion
January 31, 2019
Study Completion
March 31, 2019
Last Updated
October 31, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share