Effects of Oligo-fucoidan on Leiomyoma Patients

Early Phase 1CompletedNCT06959966

Taipei Medical University18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Uterine Leiomyoma

Interventions

PlaceboCOMBINATION_PRODUCT

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

Oligo FucoidanCOMBINATION_PRODUCT

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taipei Medical Univeersity

Taipei, Xinyi, Taiwan

Outcomes

Primary Outcomes

Change in Leiomyoma Size

the size of leiomyoma tissue (mm)

Time frame: 6 months

Change in Number of Leiomyomas

the number of leiomyoma tissue

Time frame: 6 months

Secondary Outcomes

Change in Triglyceride Level

TG (triglycerides): mg/dL

Time frame: 6 months

Change in Total Cholesterol Level

T-CHO (total cholesterol): mg/dL

Time frame: 6 months

Change in HDL Cholesterol Level

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

Time frame: 6 months

Change in LDL Cholesterol Level

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

Time frame: 6 months

Change in White Blood Cell Count

WBC (white blood cells), Unit: 10³/μL

Time frame: 6 months

Change in Red Blood Cell Count

RBC (red blood cells), Unit: 10⁶/μL

Time frame: 6 months

Change in Hemoglobin Level

HGB (hemoglobin) Unit: g/dL

Time frame: 6 months

Change in Hematocrit

HCT (hematocrit) Unit: %

Time frame: 6 months

Change in Blood Glucose

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

Time frame: 6 months

Change in High-Sensitivity C-Reactive Protein

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

Time frame: 6 months

Change in Aspartate Aminotransferase

Aspartate Aminotransferase(AST) Unit: U/L

Time frame: 6 months

Change in Alanine Aminotransferase

Alanine Aminotransferase (ALT) Unit: U/L

Time frame: 6 months

Change in Blood Urea Nitrogen

Blood Urea Nitrogen (BUN) Unit: mg/dL

Time frame: 6 months

Change in Follicle-Stimulating Hormone

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

Time frame: 6 months

Change in Albumin

Albumin (ALB) Unit: g/dL

Time frame: 6 months

Data from ClinicalTrials.gov

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