Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-03 @ 1:43 PM
Study NCT ID:
NCT04381793
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of CFS & Fibromyalgia With Recovery Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open pilot study to assess efficacy and antibody effects'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS', 'timeFrame': '6 weeks', 'description': 'Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being'}], 'secondaryOutcomes': [{'measure': 'antibody titres', 'timeFrame': '10 weeks', 'description': 'Total IgG and IgG 1-4 subsets'}, {'measure': 'FIQ-R', 'timeFrame': '6 weeks', 'description': 'Fibromyalgia severity scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Chronic Fatigue Syndrome']}, 'descriptionModule': {'briefSummary': 'The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome', 'detailedDescription': 'Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)\n\nExclusion Criteria:\n\nPregnant Clotting disorders\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04381793', 'briefTitle': 'Treatment of CFS & Fibromyalgia With Recovery Factors', 'organization': {'class': 'OTHER', 'fullName': 'Practitioners Alliance Network'}, 'officialTitle': 'Treatment of CFS & Fibromyalgia With Recovery Factors', 'orgStudyIdInfo': {'id': 'PAN study 2019-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assessing clinical efficacy', 'description': 'Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum. Pre-and post FIQ-R and VA symptom score will be assessed as well as overall well-being. In a subgroup, pre-and post antibody levels will also be checked. Phase 1 will be a group of 60 subjects', 'interventionNames': ['Dietary Supplement: Recovery Factors']}], 'interventions': [{'name': 'Recovery Factors', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Porcine serum amino acid/peptide', 'armGroupLabels': ['Assessing clinical efficacy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96740', 'city': 'Kailua', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Jacob Teitelbaum MD', 'geoPoint': {'lat': 21.40241, 'lon': -157.74054}}], 'overallOfficials': [{'name': 'Gaetano Morello, ND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Woman's Hospital in Vancouver"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Practitioners Alliance Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}