Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866995
• Other study ID #: MHCL-01-15052013
• Status: Recruiting
• Phase: Phase 3
• First received: May 29, 2013
• Last updated: May 29, 2013
• Start date: May 2013

Study information

• Verified date: May 2013
• Source: The Clinic of Men's Health and Couple Longevity, Russia
• Contact: Yuliya Tishova, MD PhD
• Phone: +79032213276
• Email: yulya_tishova[@]mail.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Processes Of The Pelvic Organs (Prostatostasis)
• Erectile Dysfunction
• Sexual Function

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Clinic Of Men's Health and Couple Longevity	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
The Clinic of Men's Health and Couple Longevity, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IPSS		3 months	No
Primary	TRUS prostate		3 months	No
Secondary	Uroflowmetry		3 months	No