Trial | NCT01866995  Report issue

Title

Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)
Phase 3 Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)Caused By Decrease Of Sexual Activity In Men.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    riluzole ...

  • Study Participants

    50
The purpose of this study is to investigate the efficacy of Phytotherapy "Raylis" (Ginseng Root Powder 50 mg, False Ginseng Root Powder 50 mg, Codonopsis Root Powder 50 mg, Astragalus Membranaceus Root Powder 50 mg, Epimedium Alpinum Herbal Extract 100 mg) In Congestive Processes Of The Pelvic Organs (Prostatostasis) In Congestive Processes Of The Pelvic Organs (Prostatostasis)
Study Started
May 31
2013
Primary Completion
Sep 30
2013
Anticipated
Last Update
Jun 03
2013
Estimate

Drug "Raylis"

"Raylis" (1 kapsule contains: ginseng root powder 50 mg, false ginseng root powder 50 mg, codonopsis root powder 50 mg, astragalus membranaceus root powder 50 mg, epimedium alpinum herbal extract 100 mg)

Other standard prostatostasis therapy

Raylis Experimental

This arm (10 men with symptoms of prostatostasis) will get "Raylis" (1 kapsule contains: ginseng root powder 50 mg, false ginseng root powder 50 mg, codonopsis root powder 50 mg, astragalus membranaceus root powder 50 mg, epimedium alpinum herbal extract 100 mg) 2 kapsules a day per 3 months

standard prostatostasis therapy Active Comparator

This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis

Raylis plus standard prostatostasis therapy Experimental

This arm (20 men with symptoms of prostatostasis) will get "Raylis" (1 kapsule contains: ginseng root powder 50 mg, false ginseng root powder 50 mg, codonopsis root powder 50 mg, astragalus membranaceus root powder 50 mg, epimedium alpinum herbal extract 100 mg) 2 kapsules a day per 3 months together with standard prostatostasis therapy

Criteria 

Inclusion Criteria:

Age 20-60 years
Symptoms of prostatostasis lasting for at least 3 months during the past 6 months:
Pathological changes on uroflowmetry (maximum flow rate of less than 15 ml / s, average urinary flow rate of less than 12 ml / sec)
TRUS Prostate volume more than 22 ml at TRUS
TRUS picture of Prostatostasis
I-PSS 7-20
IIEF-5) - 12-21

Exclusion Criteria:

Contraindications and limitations to use of the drug Raylis listed in the instructions for medical use *
Diabetes mellitus (type 1 and type 2, decompensation)
Neurogenic disorders (acute cerebral circulatory disorders, Alzheimer's disease, spinal cord injury)
A history of pelvic trauma
Patients who had undergone radical prostatectomy and other surgical interventions on the pelvic organs
Concomitant use of supplements to improve the erectile function, use of the anti-androgens, anti-depressants, finasteride.
Diagnosed BPH
Current participation in a clinical trial and / or study medication for 30 days prior to inclusion
Any form of substance abuse, mental disorder or condition which, in the opinion of the investigator, may complicate communication with the researcher.
The inability or unwillingness to comply with the scheme of visits according to protocol.
No Results Posted