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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Clinic of Men's Health and Couple Longevity, Russia
Sponsor:
Information provided by (Responsible Party):
The Clinic of Men's Health and Couple Longevity, Russia
ClinicalTrials.gov Identifier:
NCT01866995
First received: May 29, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 Intervention Phase
Congestive Processes Of The Pelvic Organs (Prostatostasis)
Erectile Dysfunction
Sexual Function
Drug: "Raylis"
Other: standard prostatostasis therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by The Clinic of Men's Health and Couple Longevity, Russia:

Primary Outcome Measures:
  • TRUS prostate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uroflowmetry [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • IPSS [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866995

Contacts
Contact: Yuliya Tishova, MD PhD +79032213276 yulya_tishova@mail.ru

Locations
Russian Federation
Clinic Of Men's Health and Couple Longevity Recruiting
Moscow, Russian Federation, 123242
Contact: Yuliya Tishova, MD PhD    +79032213276      
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
  More Information

No publications provided

Responsible Party: The Clinic of Men's Health and Couple Longevity, Russia
ClinicalTrials.gov Identifier: NCT01866995     History of Changes
Other Study ID Numbers: MHCL-01-15052013
Study First Received: May 29, 2013
Last Updated: May 29, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by The Clinic of Men's Health and Couple Longevity, Russia:
Ginseng
Prostatostasis
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014