Effects of Oligo-fucoidan on Leiomyoma Patients

Taipei Medical University

Status and phase: Completed; Early Phase 1

Conditions: Uterine Leiomyoma

Treatments: Combination Product: Placebo; Combination Product: Oligo Fucoidan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06959966

N201812056

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Starch capsule, 4 grams per day (two capsules), taken orally for six months. Capsules match the treatment group in odor and weight.

Treatment:

Combination Product: Placebo

Treatment

Experimental group

Description:

Oligo-Fucoidan capsule, 4 grams per day (two capsules), taken orally for six months.

Treatment:

Combination Product: Oligo Fucoidan