NCT02977832

Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia

A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume, improving the patient's quality of life and eventually limiting the number of patients who require surgery or endoscopy after medical treatment.

Detailed description

The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms, prostate volume, improve the patient's quality of life and eventually to limit number of patients who require surgery or endoscopy after medical treatment. To this aim, patients who seek specialist advice for LUTS with no previous surgical treatment for BPH have been selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are significantly improved, and a reduction of prostatic volume can be observed, thus changing the usual course of the disease. All patients with BPH-related LUTS received both alphalitic and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly improved, adenoma volume and post-void residual volume were significantly reduced at 12 month. This is the first clinical experience with Iresine Celosia in BPH.

Conditions

• Benign Prostatic Hypertrophy With Outflow Obstruction
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Odyliresin	Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)
DRUG	Alfuzosin	10Mg Oral Tablet, Extended Release

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2016-11-30
• Last updated: 2017-02-28

Locations

1 site across 1 country: Italy