Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-29 @ 9:38 PM
Study NCT ID:
NCT06959966
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2025-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oligo-fucoidan on Leiomyoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-04', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-05-04', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Leiomyoma Size', 'timeFrame': '6 months', 'description': 'the size of leiomyoma tissue (mm)'}, {'measure': 'Change in Number of Leiomyomas', 'timeFrame': '6 months', 'description': 'the number of leiomyoma tissue'}], 'secondaryOutcomes': [{'measure': 'Change in Triglyceride Level', 'timeFrame': '6 months', 'description': 'TG (triglycerides): mg/dL'}, {'measure': 'Change in Total Cholesterol Level', 'timeFrame': '6 months', 'description': 'T-CHO (total cholesterol): mg/dL'}, {'measure': 'Change in HDL Cholesterol Level', 'timeFrame': '6 months', 'description': 'HDL-C (high-density lipoprotein cholesterol): mg/dL'}, {'measure': 'Change in LDL Cholesterol Level', 'timeFrame': '6 months', 'description': 'LDL-C (low-density lipoprotein cholesterol): mg/dL'}, {'measure': 'Change in White Blood Cell Count', 'timeFrame': '6 months', 'description': 'WBC (white blood cells), Unit: 10³/μL'}, {'measure': 'Change in Red Blood Cell Count', 'timeFrame': '6 months', 'description': 'RBC (red blood cells), Unit: 10⁶/μL'}, {'measure': 'Change in Hemoglobin Level', 'timeFrame': '6 months', 'description': 'HGB (hemoglobin) Unit: g/dL'}, {'measure': 'Change in Hematocrit', 'timeFrame': '6 months', 'description': 'HCT (hematocrit) Unit: %'}, {'measure': 'Change in Blood Glucose', 'timeFrame': '6 months', 'description': 'Measurement: AC (blood glucose) Unit: mg/dL'}, {'measure': 'Change in High-Sensitivity C-Reactive Protein', 'timeFrame': '6 months', 'description': 'High-Sensitivity C-Reactive Protein (HS-CRP) Unit: mg/dL'}, {'measure': 'Change in Aspartate Aminotransferase', 'timeFrame': '6 months', 'description': 'Aspartate Aminotransferase(AST) Unit: U/L'}, {'measure': 'Change in Alanine Aminotransferase', 'timeFrame': '6 months', 'description': 'Alanine Aminotransferase (ALT) Unit: U/L'}, {'measure': 'Change in Blood Urea Nitrogen', 'timeFrame': '6 months', 'description': 'Blood Urea Nitrogen (BUN) Unit: mg/dL'}, {'measure': 'Change in Follicle-Stimulating Hormone', 'timeFrame': '6 months', 'description': 'Follicle-Stimulating Hormone(FSH) Unit: mIU/mL'}, {'measure': 'Change in Albumin', 'timeFrame': '6 months', 'description': 'Albumin (ALB) Unit: g/dL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Leiomyoma']}, 'descriptionModule': {'briefSummary': "Uterine leiomyoma is the most common benign tumor in women, with an incidence rate of approximately 20% among women of reproductive age. Patients may experience severe abdominal pain, abnormal bleeding, and infertility. Pathological examination of uterine specimens reveals that up to three-quarters of cases involve uterine leiomyoma, indicating that this condition is often accompanied by other uterine pathologies. Therefore, medical intervention remains necessary for affected patients. Currently, the most common treatment options include medication and surgical removal. However, the severe side effects of drug therapy and the high recurrence rate following surgical excision significantly impact patients' quality of life, underscoring the need for continued research into better treatment strategies. Fucoidan, a commercially available dietary supplement, has been shown in numerous studies to provide adjunctive therapeutic benefits for cancer patients. However, no clinical trials have been conducted to evaluate the effects of fucoidan on patients with uterine leiomyoma. Therefore, this clinical study aims to investigate the effects of fucoidan on patients with uterine leiomyoma."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Leiomyoma patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with uterine fibroids aged 20-55 years.\n* Confirmation of uterine fibroids by ultrasound (more than 3 cm, less than 10 cm).\n* There are no plans for pregnancy in the past six months.\n* There were no plans for uterine fibroid surgery for nearly six months.\n* Agree to abide by the research regulations.\n\nExclusion Criteria:\n\n* A patient with heart disease, liver disease, kidney disease or any mental illness.\n* Patients who are unable to communicate or criticize.\n* Pregnant women.\n* Patients taking regular medications, including serotonin, antidepressants or other antipsychotics.\n* Non-native speakers.'}, 'identificationModule': {'nctId': 'NCT06959966', 'briefTitle': 'Effects of Oligo-fucoidan on Leiomyoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Effects of Oligo-fucoidan on Leiomyoma Patients', 'orgStudyIdInfo': {'id': 'N201812056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Starch capsule, 4 grams per day (two capsules), taken orally for six months. Capsules match the treatment group in odor and weight.', 'interventionNames': ['Combination Product: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Oligo-Fucoidan capsule, 4 grams per day (two capsules), taken orally for six months.', 'interventionNames': ['Combination Product: Oligo Fucoidan']}], 'interventions': [{'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Starch capsule, 4 grams, two capsules per day for six months.', 'armGroupLabels': ['Placebo']}, {'name': 'Oligo Fucoidan', 'type': 'COMBINATION_PRODUCT', 'description': 'Oligo fucoidan capsule, 4 grams, two capsules per day for six months.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei', 'state': 'Xinyi', 'country': 'Taiwan', 'facility': 'Taipei Medical Univeersity', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hi-Q Marine Biotech International, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}