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

Study Overview
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Brief Summary
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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)

Official Title
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Phase 3 Study of Phytotherapy Raylis In Congestive Processes Of The Pelvic Organs (Prostatostasis)Caused By Decrease Of Sexual Activity In Men.

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

Intervention / Treatment
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* Drug: Raylis
* Other: standard prostatostasis therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raylis<br>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<br>* 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)<br>|
| Active Comparator: standard prostatostasis therapy<br>This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis | Other: standard prostatostasis therapy<br> <br> |
| Experimental: Raylis plus standard prostatostasis therapy<br>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<br>* 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)<br>Other: standard prostatostasis therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRUS prostate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflowmetry |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginseng, Prostatostasis, Erectile Dysfunction