NCT06959966

Effects of Oligo-fucoidan on Leiomyoma Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: Female
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Leiomyoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Placebo	Starch capsule, 4 grams, two capsules per day for six months.
COMBINATION_PRODUCT	Oligo Fucoidan	Oligo fucoidan capsule, 4 grams, two capsules per day for six months.

Timeline

• Start date: 2019-08-14
• Primary completion: 2022-12-01
• Completion: 2023-01-31
• First posted: 2025-05-07
• Last updated: 2025-05-07

Locations

1 site across 1 country: Taiwan