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

The Clinic of Men's Health and Couple Longevity, Russia

Status and phase: Unknown; Phase 3

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

Treatments: Drug: "Raylis"; Other: standard prostatostasis therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01866995

MHCL-01-15052013

Details and patient eligibility

About

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)

Enrollment: 50 estimated patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Raylis

Experimental group

Description:

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

Treatment:

Drug: "Raylis"

standard prostatostasis therapy

Active Comparator group

Description:

This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis

Treatment:

Other: standard prostatostasis therapy

Raylis plus standard prostatostasis therapy

Experimental group

Description:

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

Treatment:

Other: standard prostatostasis therapy

Drug: "Raylis"