Trial | NCT00797394  Report issue

Title

Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    110
The purpose of this study is to determine if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.
Study Started
Nov 30
2008
Primary Completion
Jul 31
2010
Last Update
Apr 13
2011
Estimate

Dietary Supplement Combination of 2007RD01 and saw palmetto lipidic extract

Oral administration of one capsule containing a combination of 250 mg of 2007RD01 (a natural extract) and 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals

Dietary Supplement Saw palmetto lipidic extract

Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals

Treated Experimental

Control Active Comparator

Criteria 

Inclusion Criteria:

Patient must be an adult man aged between 50 and 75
Patient must have Benign Prostatic Hyperplasia symptoms

Exclusion Criteria:

Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection
Patient has been subjected to surgery of the prostate, bladder or urethra
Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening
Patient has taken an alpha-blocker in the 2-week period preceding screening
No Results Posted