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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01866995
Other study ID # MHCL-01-15052013
Secondary ID
Status Recruiting
Phase Phase 3
First received May 29, 2013
Last updated May 29, 2013
Start date May 2013

Study information

Verified date May 2013
Source The Clinic of Men's Health and Couple Longevity, Russia
Contact Yuliya Tishova, MD PhD
Phone +79032213276
Email yulya_tishova@mail.ru
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial Summary

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)


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Russian Federation Clinic Of Men's Health and Couple Longevity Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Other IPSS 3 months No
Primary TRUS prostate 3 months No
Secondary Uroflowmetry 3 months No
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