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.

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 Overview

• Status: Unknown
• Conditions: Erectile Dysfunction; Sexual Function; Congestive Processes Of The Pelvic Organs (Prostatostasis)
• Intervention / Treatment: Drug: "Raylis"; Other: standard prostatostasis therapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 123242
    • Recruiting
    • Clinic Of Men's Health and Couple Longevity
    • Contact: Yuliya Tishova, MD PhD; Phone Number: +79032213276

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Raylis; 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	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)
Active Comparator: standard prostatostasis therapy; This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis	Other: standard prostatostasis therapy
Experimental: Raylis plus standard prostatostasis therapy; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TRUS prostate	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Uroflowmetry	3 months

Other Outcome Measures

Outcome Measure	Time Frame
IPSS	3 months

Collaborators and Investigators

• Sponsor: The Clinic of Men's Health and Couple Longevity, Russia
• Investigators: Principal Investigator: Svetlana Kalinchenko, MD PhD, Clinic of Men's Health and Couple Longevity, str Zoologicheskaya, 2-7 Moscow Russia

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 3, 2013

Study Record Updates

• Last Update Posted (Estimate): June 3, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Ginseng; Prostatostasis
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: MHCL-01-15052013