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| Name | Class |
|---|---|
| Hi-Q Marine Biotech International, Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Starch capsule, 4 grams per day (two capsules), taken orally for six months. Capsules match the treatment group in odor and weight. |
|
| Treatment | Experimental | Oligo-Fucoidan capsule, 4 grams per day (two capsules), taken orally for six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Combination Product | Starch capsule, 4 grams, two capsules per day for six months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Leiomyoma Size | the size of leiomyoma tissue (mm) | 6 months |
| Change in Number of Leiomyomas | the number of leiomyoma tissue | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Triglyceride Level | TG (triglycerides): mg/dL | 6 months |
| Change in Total Cholesterol Level | T-CHO (total cholesterol): mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
Leiomyoma patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical Univeersity | Taipei | Xinyi | 110 | Taiwan |
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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Oligo Fucoidan |
| Combination Product |
Oligo fucoidan capsule, 4 grams, two capsules per day for six months. |
|
| 6 months |
| Change in HDL Cholesterol Level | HDL-C (high-density lipoprotein cholesterol): mg/dL | 6 months |
| Change in LDL Cholesterol Level | LDL-C (low-density lipoprotein cholesterol): mg/dL | 6 months |
| Change in White Blood Cell Count | WBC (white blood cells), Unit: 10³/μL | 6 months |
| Change in Red Blood Cell Count | RBC (red blood cells), Unit: 10⁶/μL | 6 months |
| Change in Hemoglobin Level | HGB (hemoglobin) Unit: g/dL | 6 months |
| Change in Hematocrit | HCT (hematocrit) Unit: % | 6 months |
| Change in Blood Glucose | Measurement: AC (blood glucose) Unit: mg/dL | 6 months |
| Change in High-Sensitivity C-Reactive Protein | High-Sensitivity C-Reactive Protein (HS-CRP) Unit: mg/dL | 6 months |
| Change in Aspartate Aminotransferase | Aspartate Aminotransferase(AST) Unit: U/L | 6 months |
| Change in Alanine Aminotransferase | Alanine Aminotransferase (ALT) Unit: U/L | 6 months |
| Change in Blood Urea Nitrogen | Blood Urea Nitrogen (BUN) Unit: mg/dL | 6 months |
| Change in Follicle-Stimulating Hormone | Follicle-Stimulating Hormone(FSH) Unit: mIU/mL | 6 months |
| Change in Albumin | Albumin (ALB) Unit: g/dL | 6 months |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |