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

Benign Prostatic Hyperplasia Clinical Trial

— Odyliresin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977832
• Other study ID #: IRCCSPSM
• Status: Completed
• Phase: N/A
• First received: November 28, 2016
• Last updated: February 26, 2017
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy With Outflow Obstruction
• Hyperplasia
• Hypertrophy
• Prostatic Hyperplasia

Intervention

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

Drug:
• Alfuzosin
10Mg Oral Tablet, Extended Release

Locations

Country	Name	City	State
Italy	Urology Department Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score		12 months
Secondary	Maximum flow rate		12 months
Secondary	Average flow rate		12 months
Secondary	Adenoma volume		12 months
Secondary	Residual urine volume		12 months
Secondary	adverse events		12 months
Secondary	Quality of life score		12 months