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

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
"Raylis"
standard prostatostasis therapy
Sponsored by
The Clinic of Men's Health and Couple Longevity, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Processes Of The Pelvic Organs (Prostatostasis) focused on measuring Ginseng, Prostatostasis, Erectile Dysfunction

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinic Of Men's Health and Couple LongevityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Raylis

standard prostatostasis therapy

Raylis plus standard prostatostasis therapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

TRUS prostate

Secondary Outcome Measures

Uroflowmetry

Full Information

First Posted
May 29, 2013
Last Updated
May 29, 2013
Sponsor
The Clinic of Men's Health and Couple Longevity, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT01866995
Brief Title
Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)
Official Title
Phase 3 Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)Caused By Decrease Of Sexual Activity In Men.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Clinic of Men's Health and Couple Longevity, Russia

4. Oversight

5. Study Description

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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Processes Of The Pelvic Organs (Prostatostasis), Erectile Dysfunction, Sexual Function
Keywords
Ginseng, Prostatostasis, Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Raylis
Arm Type
Experimental
Arm Description
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
Arm Title
standard prostatostasis therapy
Arm Type
Active Comparator
Arm Description
This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis
Arm Title
Raylis plus standard prostatostasis therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
"Raylis"
Intervention Description
"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)
Intervention Type
Other
Intervention Name(s)
standard prostatostasis therapy
Primary Outcome Measure Information:
Title
TRUS prostate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Uroflowmetry
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
IPSS
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuliya Tishova, MD PhD
Phone
+79032213276
Email
yulya_tishova@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svetlana Kalinchenko, MD PhD
Organizational Affiliation
Clinic of Men's Health and Couple Longevity, str Zoologicheskaya, 2-7 Moscow Russia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic Of Men's Health and Couple Longevity
City
Moscow
ZIP/Postal Code
123242
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuliya Tishova, MD PhD
Phone
+79032213276

12. IPD Sharing Statement

Learn more about this trial

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

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