Uterine Leiomyoma
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTPlacebo
Starch capsule, 4 grams, two capsules per day for six months.
COMBINATION_PRODUCTOligo Fucoidan
Oligo fucoidan capsule, 4 grams, two capsules per day for six months.
Sponsors
Hi-Q Marine Biotech International, Ltd.
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Women with uterine fibroids aged 20-55 years. * Confirmation of uterine fibroids by ultrasound (more than 3 cm, less than 10 cm). * There are no plans for pregnancy in the past six months. * There were no plans for uterine fibroid surgery for nearly six months. * Agree to abide by the research regulations.
Exclusion criteria
* A patient with heart disease, liver disease, kidney disease or any mental illness. * Patients who are unable to communicate or criticize. * Pregnant women. * Patients taking regular medications, including serotonin, antidepressants or other antipsychotics. * Non-native speakers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Leiomyoma Size | 6 months | the size of leiomyoma tissue (mm) |
| Change in Number of Leiomyomas | 6 months | the number of leiomyoma tissue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HDL Cholesterol Level | 6 months | HDL-C (high-density lipoprotein cholesterol): mg/dL |
| Change in LDL Cholesterol Level | 6 months | LDL-C (low-density lipoprotein cholesterol): mg/dL |
| Change in White Blood Cell Count | 6 months | WBC (white blood cells), Unit: 10³/μL |
| Change in Red Blood Cell Count | 6 months | RBC (red blood cells), Unit: 10⁶/μL |
| Change in Hemoglobin Level | 6 months | HGB (hemoglobin) Unit: g/dL |
| Change in Hematocrit | 6 months | HCT (hematocrit) Unit: % |
| Change in Triglyceride Level | 6 months | TG (triglycerides): mg/dL |
| Change in High-Sensitivity C-Reactive Protein | 6 months | High-Sensitivity C-Reactive Protein (HS-CRP) Unit: mg/dL |
| Change in Aspartate Aminotransferase | 6 months | Aspartate Aminotransferase(AST) Unit: U/L |
| Change in Alanine Aminotransferase | 6 months | Alanine Aminotransferase (ALT) Unit: U/L |
| Change in Blood Urea Nitrogen | 6 months | Blood Urea Nitrogen (BUN) Unit: mg/dL |
| Change in Follicle-Stimulating Hormone | 6 months | Follicle-Stimulating Hormone(FSH) Unit: mIU/mL |
| Change in Albumin | 6 months | Albumin (ALB) Unit: g/dL |
| Change in Blood Glucose | 6 months | Measurement: AC (blood glucose) Unit: mg/dL |
| Change in Total Cholesterol Level | 6 months | T-CHO (total cholesterol): mg/dL |
Countries
Taiwan
Outcome results
None listed