Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)
NCT ID: NCT01866995
Last Updated: 2013-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
"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)
standard prostatostasis therapy
This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis
standard prostatostasis therapy
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
"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)
standard prostatostasis therapy
Interventions
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"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)
standard prostatostasis therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
60 Years
MALE
No
Sponsors
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The Clinic of Men's Health and Couple Longevity, Russia
OTHER
Responsible Party
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Principal Investigators
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Svetlana Kalinchenko, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Clinic of Men's Health and Couple Longevity, str Zoologicheskaya, 2-7 Moscow Russia
Locations
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Clinic Of Men's Health and Couple Longevity
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Yuliya Tishova, MD PhD
Role: primary
Other Identifiers
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MHCL-01-15052013
Identifier Type: -
Identifier Source: org_study_id
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