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

NCT ID: NCT02977832

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

Brief 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

Keywords

LUTS; Iresine celosia; Odyliresin; medical therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

odyliresin

Odyliresin (Iresine celosia) 2 ml

Group Type: EXPERIMENTAL

Odyliresin

Intervention Type: DIETARY_SUPPLEMENT

Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)

Alfuzosin

Intervention Type: DRUG

10Mg Oral Tablet, Extended Release

alphalytic

alpha-antagonist (alfuzosin 10 mg)

Group Type: EXPERIMENTAL

Odyliresin

Intervention Type: DIETARY_SUPPLEMENT

Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)

Alfuzosin

Intervention Type: DRUG

10Mg Oral Tablet, Extended Release

Interventions

Odyliresin

Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)

Intervention Type: DIETARY_SUPPLEMENT

Alfuzosin

10Mg Oral Tablet, Extended Release

Intervention Type: DRUG

Other Intervention Names

Iresine Celosia; alphalytic

Eligibility Criteria

Inclusion Criteria

• 45 years of age or older
• Clinically diagnosed with mild to moderate BPH
• Prostatic volume ≥ 30 ml determined by transrectal ultrasound
• Maximum flow rate (Qmax) < 15 ml/sec for a voided volume 150-500 ml

Exclusion Criteria

• Participants must not have severe BPH (IPSS symptom score >21)
• Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin).
• Patients must not have undergone prior transurethral resection of the prostate (TURP).
• Post void residual (PVD) > 200 ml
• Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Daniele Porru

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmine Tinelli, MD

Role: STUDY_CHAIR

Ethics Committee

Locations

Urology Department Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Countries

Italy

References

Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.

Reference Type: BACKGROUND

PMID: 18533373 (View on PubMed)

Other Identifiers

IRCCSPSM

Identifier Type: -

Identifier Source: org_study_id