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

Sponsor
IRCCS Policlinico S. Matteo (Other)
Overall Status
Completed
CT.gov ID
NCT02977832
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
20
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: odyliresin

Odyliresin (Iresine celosia) 2 ml

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

    • Drug: Alfuzosin
    10Mg Oral Tablet, Extended Release
    Other Names:
  • alphalytic

    		•
    Experimental: alphalytic

    alpha-antagonist (alfuzosin 10 mg)

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

    • Drug: Alfuzosin
    10Mg Oral Tablet, Extended Release
    Other Names:
  • alphalytic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. International Prostate Symptom Score [12 months]

    Secondary Outcome Measures

    1. Maximum flow rate [12 months]

    2. Average flow rate [12 months]

    3. Adenoma volume [12 months]

    4. Residual urine volume [12 months]

    5. adverse events [12 months]

    6. Quality of life score [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Department Fondazione IRCCS Policlinico San Matteo Pavia Italy 27100

    Sponsors and Collaborators

    • IRCCS Policlinico S. Matteo

    Investigators

    • Study Chair: Carmine Tinelli, MD, Ethics Committee

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Daniele Porru, MD, IRCCS Policlinico S. Matteo
    ClinicalTrials.gov Identifier:
    NCT02977832
    Other Study ID Numbers:
    • IRCCSPSM
    First Posted:
    Nov 30, 2016
    Last Update Posted:
    Feb 28, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Daniele Porru, MD, IRCCS Policlinico S. Matteo
    LUTS
    Iresine celosia
    Odyliresin
    medical therapy
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Hypertrophy
    Alfuzosin

    Study Results

    No Results Posted as of Feb 28, 2017