Congestive Processes Of The Pelvic Organs (Prostatostasis)Phase 3NCT01866995
Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)
A Phase 3 study testing "Raylis" and standard prostatostasis therapy in people with Congestive Processes Of The Pelvic Organs (Prostatostasis) and Erectile Dysfunction, run by The Clinic of Men's Health and Couple Longevity, Russia at 1 site in Russia.
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)… Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Congestive Processes Of The Pelvic Organs (Prostatostasis), Erectile Dysfunction, Sexual Function
- What is being tested?
- "Raylis" and standard prostatostasis therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- May 2013to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic Of Men's Health and Couple Longevity
Moscow, 123242
Yuliya Tishova, MD PhD, +79032213276
About this study
Official title: Phase 3 Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)Caused By Decrease Of Sexual Activity In Men.
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)
- Conditions
- Congestive Processes Of The Pelvic Organs (Prostatostasis), Erectile Dysfunction, Sexual Function
- Being tested
- "Raylis", standard prostatostasis therapy
- Keywords
- Ginseng, Prostatostasis, Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Raylis"Drug
"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 therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Raylis | Experimental | 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 Receives: Drug: "Raylis" |
| standard prostatostasis therapy | Active comparator | This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis Receives: Other: standard prostatostasis therapy |
| Raylis plus standard prostatostasis therapy | Experimental | 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 Receives: Drug: "Raylis"; Other: standard prostatostasis therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRUS prostate
Measured: 3 months
Secondary outcomes (1)
Uroflowmetry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Processes Of The Pelvic Organs (Prostatostasis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Clinic of Men's Health and Couple Longevity, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svetlana Kalinchenko, MD PhD, Principal investigator, Clinic of Men's Health and Couple Longevity, str Zoologicheskaya, 2-7 Moscow Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866995
- Sponsor's protocol ID
- MHCL-01-15052013
- Status last verified
- May 2013
- First submitted
- 29 May 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)Caused By Decrease Of Sexual Activity In Men.
- ClinicalTrials.gov ID
- NCT01866995
- Acronym / sponsor ID
- MHCL-01-15052013
- Conditions
- Congestive Processes Of The Pelvic Organs (Prostatostasis), Erectile Dysfunction, Sexual Function
- Keywords
- Ginseng, Prostatostasis, Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Clinic of Men's Health and Couple Longevity, RussiaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2013 (estimated)
- First posted
- 3 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Raylis | Experimental | Drug: "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 |
| standard prostatostasis therapy | Active comparator | Other: standard prostatostasis therapyThis arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis |
| Raylis plus standard prostatostasis therapy | Experimental | Drug: "Raylis", Other: standard prostatostasis therapyThis 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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) | Drug | Raylis, Raylis plus standard prostatostasis therapy |
| standard prostatostasis therapy | Other | Raylis plus standard prostatostasis therapy, standard prostatostasis therapy |
Primary outcome
TRUS prostate
Time frame: 3 months
1 secondary outcome
Uroflowmetry
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana Kalinchenko, MD PhD principal investigator
Clinic of Men's Health and Couple Longevity, str Zoologicheskaya, 2-7 Moscow Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing "Raylis" and standard prostatostasis therapy in people with Congestive Processes Of The Pelvic Organs (Prostatostasis) and Erectile Dysfunction, run by The Clinic of Men's Health and Couple Longevity, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuliya Tishova, MD PhD (+79032213276, yulya_tishova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRUS prostate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2013.