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

NCT02977832 | Completed DMC

• 1 other identifier: IRCCSPSM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hypertrophy With Outflow Obstruction; Benign Prostatic Hyperplasia

Keywords

LUTS; Iresine celosia; Odyliresin; medical therapy

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score

  12 months

Secondary Outcomes (6)

• Maximum flow rate

  12 months

• Average flow rate

  12 months

• Adenoma volume

  12 months

• Residual urine volume

  12 months

• adverse events

  12 months

Study Arms (2)

odyliresin

EXPERIMENTAL

Odyliresin (Iresine celosia) 2 ml

Dietary Supplement: Odyliresin; Drug: Alfuzosin

alphalytic

EXPERIMENTAL

alpha-antagonist (alfuzosin 10 mg)

Dietary Supplement: Odyliresin; Drug: Alfuzosin

Interventions

Odyliresin DIETARY_SUPPLEMENT

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

Also known as: Iresine Celosia

alphalytic; odyliresin

Alfuzosin DRUG

10Mg Oral Tablet, Extended Release

Also known as: alphalytic

alphalytic; odyliresin

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Urology Department Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

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

  PMID: 18533373 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Carmine Tinelli, MD

  Ethics Committee

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

IT (1)