Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
Study NCT ID:
NCT01866995
Status:
UNKNOWN
Last Update Posted:
2013-06-03
First Post:
2013-05-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-05-29', 'lastUpdatePostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'IPSS', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'TRUS prostate', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Uroflowmetry', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['Ginseng', 'Prostatostasis', 'Erectile Dysfunction'], 'conditions': ['Congestive Processes Of The Pelvic Organs (Prostatostasis)', 'Erectile Dysfunction', 'Sexual Function']}, 'descriptionModule': {'briefSummary': '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)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 20-60 years\n* Symptoms of prostatostasis lasting for at least 3 months during the past 6 months:\n* Pathological changes on uroflowmetry (maximum flow rate of less than 15 ml / s, average urinary flow rate of less than 12 ml / sec)\n* TRUS Prostate volume more than 22 ml at TRUS\n* TRUS picture of Prostatostasis\n* I-PSS 7-20\n* IIEF-5) - 12-21\n\nExclusion Criteria:\n\n* Contraindications and limitations to use of the drug Raylis listed in the instructions for medical use \\*\n* Diabetes mellitus (type 1 and type 2, decompensation)\n* Neurogenic disorders (acute cerebral circulatory disorders, Alzheimer's disease, spinal cord injury)\n* A history of pelvic trauma\n* Patients who had undergone radical prostatectomy and other surgical interventions on the pelvic organs\n* Concomitant use of supplements to improve the erectile function, use of the anti-androgens, anti-depressants, finasteride.\n* Diagnosed BPH\n* Current participation in a clinical trial and / or study medication for 30 days prior to inclusion\n* Any form of substance abuse, mental disorder or condition which, in the opinion of the investigator, may complicate communication with the researcher.\n* The inability or unwillingness to comply with the scheme of visits according to protocol."}, 'identificationModule': {'nctId': 'NCT01866995', 'briefTitle': 'Efficacy Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)', 'organization': {'class': 'OTHER', 'fullName': "The Clinic of Men's Health and Couple Longevity, Russia"}, 'officialTitle': 'Phase 3 Study of Phytotherapy "Raylis" In Congestive Processes Of The Pelvic Organs (Prostatostasis)Caused By Decrease Of Sexual Activity In Men.', 'orgStudyIdInfo': {'id': 'MHCL-01-15052013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raylis', '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', 'interventionNames': ['Drug: "Raylis"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard prostatostasis therapy', 'description': 'This arm (20 men with symptoms of prostatostasis) will get the standard (pathogenetic) therapy of prostatostasis', 'interventionNames': ['Other: standard prostatostasis therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Raylis plus standard prostatostasis therapy', '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', 'interventionNames': ['Drug: "Raylis"', 'Other: standard prostatostasis therapy']}], 'interventions': [{'name': '"Raylis"', 'type': 'DRUG', 'description': '"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)', 'armGroupLabels': ['Raylis', 'Raylis plus standard prostatostasis therapy']}, {'name': 'standard prostatostasis therapy', 'type': 'OTHER', 'armGroupLabels': ['Raylis plus standard prostatostasis therapy', 'standard prostatostasis therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123242', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Yuliya Tishova, MD PhD', 'role': 'CONTACT', 'phone': '+79032213276'}], 'facility': "Clinic Of Men's Health and Couple Longevity", 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Yuliya Tishova, MD PhD', 'role': 'CONTACT', 'email': 'yulya_tishova@mail.ru', 'phone': '+79032213276'}], 'overallOfficials': [{'name': 'Svetlana Kalinchenko, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Clinic of Men's Health and Couple Longevity, str Zoologicheskaya, 2-7 Moscow Russia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The Clinic of Men's Health and Couple Longevity, Russia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}