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Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2013 by The Clinic of Men's Health and Couple Longevity, Russia.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
The Clinic of Men's Health and Couple Longevity, Russia
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
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 Genital Diseases, Male Mental Disorders |
Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders |
ClinicalTrials.gov processed this record on January 03, 2016
