An interventional study of Odyliresin and Alfuzosin in Benign Prostatic Hypertrophy With Outflow Obstruction and Benign Prostatic Hyperplasia, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 1 site in Italy. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Treatment
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.
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 30 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.
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Exclusion Criteria:
Odyliresin (Iresine celosia) 2 ml
Dietary Supplement: Odyliresin · Drug: Alfuzosin
alpha-antagonist (alfuzosin 10 mg)
Dietary Supplement: Odyliresin · Drug: Alfuzosin
Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)
Also known as: Iresine Celosia
10Mg Oral Tablet, Extended Release
Also known as: alphalytic
International Prostate Symptom Score
Time frame: 12 months
Maximum flow rate
Time frame: 12 months
Average flow rate
Time frame: 12 months
Adenoma volume
Time frame: 12 months
Residual urine volume
Time frame: 12 months
adverse events
Time frame: 12 months
Quality of life score
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Policlinico San Matteo di Pavia