Clinical trial NCT06959966: Effects of Oligo-fucoidan on Leiomyoma Patients
Official title: Effects of Oligo-fucoidan on Leiomyoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Uterine Leiomyoma
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Hi-Q Marine Biotech International, Ltd.
First posted: 2025-05-07
Enrollment: 18
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Leiomyoma Size
timeFrame: 6 months
measure: Change in Number of Leiomyomas
timeFrame: 6 months
Secondary outcomes:
measure: Change in Triglyceride Level
timeFrame: 6 months
measure: Change in Total Cholesterol Level
timeFrame: 6 months
measure: Change in HDL Cholesterol Level
timeFrame: 6 months
measure: Change in LDL Cholesterol Level
timeFrame: 6 months
measure: Change in White Blood Cell Count
timeFrame: 6 months
measure: Change in Red Blood Cell Count
timeFrame: 6 months
measure: Change in Hemoglobin Level
timeFrame: 6 months
measure: Change in Hematocrit
timeFrame: 6 months
measure: Change in Blood Glucose
timeFrame: 6 months
measure: Change in High-Sensitivity C-Reactive Protein
timeFrame: 6 months
measure: Change in Aspartate Aminotransferase
timeFrame: 6 months
measure: Change in Alanine Aminotransferase
timeFrame: 6 months
measure: Change in Blood Urea Nitrogen
timeFrame: 6 months
measure: Change in Follicle-Stimulating Hormone
timeFrame: 6 months
measure: Change in Albumin
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical Univeersity
state: Xinyi
Study officials:
References: