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Completed

NCT Number: NCT06959966

Effects of Oligo-fucoidan on Leiomyoma Patients

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.

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Key information

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Taipei Medical Univeersity

Taipei, Xinyi, 110, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Combination Product

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

Oligo Fucoidan

Combination Product

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

Primary outcomes

  1. Change in Leiomyoma Size

    Time frame: 6 months

    the size of leiomyoma tissue (mm)

  2. Change in Number of Leiomyomas

    Time frame: 6 months

    the number of leiomyoma tissue

Secondary outcomes

  1. Change in Triglyceride Level

    Time frame: 6 months

    TG (triglycerides): mg/dL

  2. Change in Total Cholesterol Level

    Time frame: 6 months

    T-CHO (total cholesterol): mg/dL

  3. Change in HDL Cholesterol Level

    Time frame: 6 months

    HDL-C (high-density lipoprotein cholesterol): mg/dL

  4. Change in LDL Cholesterol Level

    Time frame: 6 months

    LDL-C (low-density lipoprotein cholesterol): mg/dL

  5. Change in White Blood Cell Count

    Time frame: 6 months

    WBC (white blood cells), Unit: 10³/μL

  6. Change in Red Blood Cell Count

    Time frame: 6 months

    RBC (red blood cells), Unit: 10⁶/μL

  7. Change in Hemoglobin Level

    Time frame: 6 months

    HGB (hemoglobin) Unit: g/dL

  8. Change in Hematocrit

    Time frame: 6 months

    HCT (hematocrit) Unit: %

  9. Change in Blood Glucose

    Time frame: 6 months

    Measurement: AC (blood glucose) Unit: mg/dL

  10. Change in High-Sensitivity C-Reactive Protein

    Time frame: 6 months

    High-Sensitivity C-Reactive Protein (HS-CRP) Unit: mg/dL

  11. Change in Aspartate Aminotransferase

    Time frame: 6 months

    Aspartate Aminotransferase(AST) Unit: U/L

  12. Change in Alanine Aminotransferase

    Time frame: 6 months

    Alanine Aminotransferase (ALT) Unit: U/L

  13. Change in Blood Urea Nitrogen

    Time frame: 6 months

    Blood Urea Nitrogen (BUN) Unit: mg/dL

  14. Change in Follicle-Stimulating Hormone

    Time frame: 6 months

    Follicle-Stimulating Hormone(FSH) Unit: mIU/mL

  15. Change in Albumin

    Time frame: 6 months

    Albumin (ALB) Unit: g/dL

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • Hi-Q Marine Biotech International, Ltd.

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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