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

Sponsor
The Clinic of Men's Health and Couple Longevity, Russia (Other)
Overall Status
Unknown status
CT.gov ID
NCT01866995
Collaborator
(none)
50
Enrollment
1
Location
3
Arms

Study Details

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)

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. TRUS prostate [3 months]

Secondary Outcome Measures

  1. Uroflowmetry [3 months]

Other Outcome Measures

  1. IPSS [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinic Of Men's Health and Couple Longevity Moscow Russian Federation 123242

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Clinic of Men's Health and Couple Longevity, Russia
ClinicalTrials.gov Identifier:
NCT01866995
Other Study ID Numbers:
  • MHCL-01-15052013
First Posted:
Jun 3, 2013
Last Update Posted:
Jun 3, 2013
Last Verified:
May 1, 2013
Keywords provided by The Clinic of Men's Health and Couple Longevity, Russia
Ginseng
Prostatostasis
Erectile Dysfunction
Additional relevant MeSH terms:
Erectile Dysfunction

Study Results

No Results Posted as of Jun 3, 2013