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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146103
• Other study ID #: AJ13
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: October 2019
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Lebanon	Elie El Helou	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (10)

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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Kaminetsky J. Comorbid LUTS and erectile dysfunction: optimizing their management. Curr Med Res Opin. 2006 Dec;22(12):2497-506. Review. — View 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. Review. — View 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. — View 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. — View 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. do — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS	Change in IPSS	At 1 and 3 months visits
Secondary	IPSS subscores	Change in IPSS subscores (voiding, filling, nocturia)	At 1 and 3 months visits
Secondary	uQoL	Change in uQoL	At 1 and 3 months visits
Secondary	IIEF-5	Change in IIEF-5	At 1 and 3 months visits
Secondary	Rate of ejaculatory dysfunction and orthostatic hypotension	Rate	At 1 and 3 months visits