Status:
UNKNOWN
Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)
Lead Sponsor:
The Clinic of Men's Health and Couple Longevity, Russia
Conditions:
Congestive Processes Of The Pelvic Organs (Prostatostasis)
Erectile Dysfunction
Eligibility:
MALE
20-60 years
Phase:
PHASE3
Brief Summary
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 Roo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01866995
Start Date
May 1 2013
Last Update
June 3 2013
Active Locations (1)
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1
Clinic Of Men's Health and Couple Longevity
Moscow, Russia, 123242