Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT04141969
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2019-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077342', 'term': 'Post-Lyme Disease Syndrome'}], 'ancestors': [{'id': 'D008193', 'term': 'Lyme Disease'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-09', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS Global-10', 'timeFrame': '6 months', 'description': 'PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .'}, {'measure': 'IHT Blood Test Assessment', 'timeFrame': '6 months', 'description': 'Outcome measure of "positive" or "negative" for antibodies; IgG P93 Ab. IgG P66 Ab. IgG P58 Ab. IgG P45 Ab. IgG P41 Ab. IgG P39 Ab. IgG P30 Ab. IgG P28 Ab. IgG P23 Ab. IgG P18 Ab.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lyme'], 'conditions': ['Post-Lyme Disease Syndrome (PLDS)']}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.', 'detailedDescription': 'A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome will be evaluated during a double blind, placebo controlled study. This study is an expansion of RLP042019 NCT04078841 Treating Post-Lyme Disease Syndrome With Acetogenins'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A positive two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.\n2. Must be able to swallow a mixed powder drink.\n\nExclusion Criteria:\n\n1 .Non Positive Western Blot test.\n\n2\\. Positive Western Blot test where the individual has not been treated with antibiotics.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04141969', 'acronym': 'PLDS', 'briefTitle': 'A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Optimal Health Research'}, 'officialTitle': 'A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome', 'orgStudyIdInfo': {'id': 'RLP10242019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RLP', 'description': 'ReaLife+', 'interventionNames': ['Dietary Supplement: RLP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inert', 'description': 'Inert brown powder to look similar to RLP', 'interventionNames': ['Other: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Not given RLP or the placebo'}], 'interventions': [{'name': 'RLP', 'type': 'DIETARY_SUPPLEMENT', 'description': 'RLP nutraceutical', 'armGroupLabels': ['RLP']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Inert brown powder', 'armGroupLabels': ['Inert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Optimal Health Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Dr Osguthorpe, ND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Optimal Health Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimal Health Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}