Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-24 @ 3:58 AM
Study NCT ID:
NCT01651468
Status:
WITHDRAWN
Last Update Posted:
2017-11-28
First Post:
2012-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Nutraceutical "Hemofix" on the Coagulation System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014842', 'term': 'von Willebrand Diseases'}, {'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The collaborator lost interest in a clinical study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-26', 'studyFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bleeding and blood test results', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mild bleeding disorder'], 'conditions': ['Von Willebrand Disease', 'Menorrhagia']}, 'descriptionModule': {'briefSummary': 'Hemofix is a herbal formula based on traditional Jewish and far eastern medicine created to assist in wound healing and bleeding arrest. It contains herbs such as Red Clover, Liquorice, Raspberry, Ginger and more. The present study will evaluate the formula on the coagulation system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers and volunteers with a mild bleeding disorder\n\nExclusion Criteria:\n\n* people with thrombophilic and cardiovascular complications,\n* people who are treated with anti-coagulants,\n* women taking birth control pills\n* people with a history hypercoagulability'}, 'identificationModule': {'nctId': 'NCT01651468', 'briefTitle': 'The Effect of the Nutraceutical "Hemofix" on the Coagulation System', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Phase 1 Study of the Nutraceutical "Hemofix" Safety and Effect on the Coagulation System', 'orgStudyIdInfo': {'id': 'HEMOFIX- HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEMOFIX', 'description': '3 grams a day', 'interventionNames': ['Dietary Supplement: HEMOFIX']}], 'interventions': [{'name': 'HEMOFIX', 'type': 'DIETARY_SUPPLEMENT', 'description': 'unique complex herbal mixture', 'armGroupLabels': ['HEMOFIX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'David Varon, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HMO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'HEMOFIX', 'class': 'UNKNOWN'}, {'name': 'Yocheved Grossman', 'class': 'UNKNOWN'}, {'name': 'Idan Grossman', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}