Effects of Oligo-fucoidan on Leiomyoma Patients

NCT ID: NCT06959966

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-14
• Study Completion Date: 2023-01-31

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.

Conditions

Uterine Leiomyoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: COMBINATION_PRODUCT

Starch capsule, 4 grams, two capsules per day for six months.

Treatment

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

Group Type: EXPERIMENTAL

Oligo Fucoidan

Intervention Type: COMBINATION_PRODUCT

Oligo fucoidan capsule, 4 grams, two capsules per day for six months.

Interventions

Placebo

Starch capsule, 4 grams, two capsules per day for six months.

Intervention Type: COMBINATION_PRODUCT

Oligo Fucoidan

Oligo fucoidan capsule, 4 grams, two capsules per day for six months.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hi-Q Marine Biotech International, Ltd.

INDUSTRY

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Medical Univeersity

Taipei, Xinyi, Taiwan

Countries

Taiwan

Other Identifiers

N201812056

Identifier Type: -

Identifier Source: org_study_id