Effects of Oligo-fucoidan on Leiomyoma Patients

Early Phase 1

Completed

• Conditions: Uterine Leiomyoma

• Registration Number: NCT06959966
• Lead Sponsor: Taipei Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-14
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-05-04
• Last Update Submitted: 2025-05-04
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Leiomyoma Size	6 months	the size of leiomyoma tissue (mm)
Change in Number of Leiomyomas	6 months	the number of leiomyoma tissue

Secondary Outcome Measures

Name	Time	Method
Change in Triglyceride Level	6 months	TG (triglycerides): mg/dL
Change in Total Cholesterol Level	6 months	T-CHO (total cholesterol): mg/dL
Change in HDL Cholesterol Level	6 months	HDL-C (high-density lipoprotein cholesterol): mg/dL
Change in LDL Cholesterol Level	6 months	LDL-C (low-density lipoprotein cholesterol): mg/dL
Change in Red Blood Cell Count	6 months	RBC (red blood cells), Unit: 10⁶/μL
Change in Hematocrit	6 months	HCT (hematocrit) Unit: %
Change in White Blood Cell Count	6 months	WBC (white blood cells), Unit: 10³/μL
Change in Hemoglobin Level	6 months	HGB (hemoglobin) Unit: g/dL
Change in Blood Glucose	6 months	Measurement: AC (blood glucose) Unit: mg/dL
Change in High-Sensitivity C-Reactive Protein	6 months	High-Sensitivity C-Reactive Protein (HS-CRP) Unit: mg/dL
Change in Aspartate Aminotransferase	6 months	Aspartate Aminotransferase(AST) Unit: U/L
Change in Alanine Aminotransferase	6 months	Alanine Aminotransferase (ALT) Unit: U/L
Change in Blood Urea Nitrogen	6 months	Blood Urea Nitrogen (BUN) Unit: mg/dL
Change in Follicle-Stimulating Hormone	6 months	Follicle-Stimulating Hormone(FSH) Unit: mIU/mL
Change in Albumin	6 months	Albumin (ALB) Unit: g/dL

Trial Locations

Locations (1)

Taipei Medical Univeersity; 🇨🇳 Taipei, Xinyi, Taiwan