Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-25 @ 10:43 AM
Study NCT ID:
NCT03681392
Status:
WITHDRAWN
Last Update Posted:
2021-12-20
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dr. Pyke's Supplement for Stream (S4S) in Men With Prostatism and ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053448', 'term': 'Prostatism'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045483', 'term': 'Rivers'}], 'ancestors': [{'id': 'D055593', 'term': 'Geological Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D005618', 'term': 'Fresh Water'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized open-label crossover design with 1:1 allocation of first regimen as once daily or twice daily'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-04', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-20', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serious adverse events', 'timeFrame': '2 weeks', 'description': 'Rate of reported diagnoses from treating physicians if any subjects are hospitalized'}], 'primaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': '1-4 weeks', 'description': 'measure of lower urinary tract symptoms in men with prostatism, total score; 0=best possible (no symptoms); 35 = worst possible; mean change and number of patients 50% improved'}, {'measure': 'Primary safety outcome: adverse events', 'timeFrame': '1 week', 'description': 'Reports from subjects of new or worse symptoms; number of patients with any adverse event, count and % of patients with each type of such adverse events'}], 'secondaryOutcomes': [{'measure': 'Secondary safety outcome: Adverse event dropouts', 'timeFrame': '1-2 weeks', 'description': 'Reports from subjects; number and % of patients'}, {'measure': 'International Prostate Symptoms Scale Quality of Life due to urinary symptoms', 'timeFrame': '1-4 weeks', 'description': 'categorical single-item self-report from "delighted" to "terrible" plus brief write-in; % improving by at least 1 point'}, {'measure': "Volunteer's Global Impression of Change in Erectile function", 'timeFrame': '1 week', 'description': 'categorical single-item self-report from "very much improved" to "worse" plus brief write-in; % improvement by at least 1 point'}, {'measure': 'International Index of Erectile Function (IIEF)-5', 'timeFrame': '1-4 weeks', 'description': '5-item cluster on erectile function, score = 5 (worst possible) to 25 (completely normal); mean change and % improving by at least 2 points'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benign Prostatic Hypertrophy', 'Erectile Dysfunction', 'Nutritional Supplements', 'Prostatism', 'Lower Urinary Tract Symptoms, male'], 'conditions': ['Prostatism', 'Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '30301704', 'type': 'BACKGROUND', 'citation': 'Pyke RE. Exo-Clinical Trials of Nutritional Supplements for Sexual Dysfunction: Precedents, Principles, and Protocols. Sex Med Rev. 2019 Apr;7(2):251-258. doi: 10.1016/j.sxmr.2018.07.002. Epub 2018 Oct 6.'}]}, 'descriptionModule': {'briefSummary': "This is the first clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3, to investigate its effects on prostatism and erections, and its tolerability, when taken daily and twice-daily for 2 weeks.", 'detailedDescription': "This is a 2-week clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrullline, beta-sitosterol and vitamin D3, investigating its lower urinary tract effects, sexual effects, and tolerability in two dose regimens-daily for a week and twice daily for a week--in men who have Lower Urinary Tract Symptoms (LUTS) and may have erectile dysfunction (ED). No clinic visits are required. Subjects will be consented, screened, supplied with S4S, and tested via the Internet. Subset analyses will evaluate effects in three populations: men with at least moderate lower urinary tract symptoms (LUTS), according to standard score cutoff; men with at least moderate Erectile Dysfunction (ED, according to standard score cutoff; and all men dissatisfied with their urinary function and meeting minimal criteria for inclusion."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Male prostate gland dysfunction is required', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion requirements for all subjects\n\n1. Men at least 40 years of age\n2. Screening IPSS QoL must be 4-6:\n\n If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6)\n3. Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations\n4. Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment\n\nRequired for target efficacy subset\n\nMeets criterion for at least moderate ED: IIEF-5 (erectile function) score \\<13 - or:\n\nMeets criterion for at least moderate Lower urinary tract symptoms (LUTS): IPSS score at least 20\n\nExclusion Criteria:\n\n1. Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil.\n2. Current severe side effects from any drug\n3. Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study.\n4. Women'}, 'identificationModule': {'nctId': 'NCT03681392', 'acronym': 'S4S4BPH/ED', 'briefTitle': "Study of Dr. Pyke's Supplement for Stream (S4S) in Men With Prostatism and ED", 'organization': {'class': 'INDUSTRY', 'fullName': 'drpykessupplements.com'}, 'officialTitle': "A Phase 2 Open-label Randomized Crossover Dose-finding Study of the Efficacy, Safety, and Tolerability of Dr. Pyke's Supplement for Stream (S4S) in Older Men With Lower Urinary Tract Symptoms and/or Sexual Dysfunction", 'orgStudyIdInfo': {'id': 'Pykonsult 2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Once daily then twice daily', 'description': 'One 6.5 cc scoop of S4S once a day for 7 days, then one 6.5 cc scoop of S4S twice a day for 7 days', 'interventionNames': ["Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)"]}, {'type': 'EXPERIMENTAL', 'label': 'Twice daily then once daily', 'description': 'One 6.5 cc scoop of S4S twice a day for 7 days, then one 6.5 cc scoop of S4S once a day for 7 days', 'interventionNames': ["Dietary Supplement: Dr. Pyke's Supplement for Stream (S4S)"]}], 'interventions': [{'name': "Dr. Pyke's Supplement for Stream (S4S)", 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['S4S'], 'description': 'Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3', 'armGroupLabels': ['Once daily then twice daily', 'Twice daily then once daily']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert E Pyke, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pykonsult LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert E. Pyke', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Trial Investigator', 'investigatorFullName': 'Robert E. Pyke', 'investigatorAffiliation': 'drpykessupplements.com'}}}}