Effects of Oligo-fucoidan on Leiomyoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Leiomyoma Size
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Leiomyoma Size
时间窗: 6 months
the size of leiomyoma tissue (mm)
Change in Number of Leiomyomas
时间窗: 6 months
the number of leiomyoma tissue
次要结局
- Change in Triglyceride Level(6 months)
- Change in Total Cholesterol Level(6 months)
- Change in HDL Cholesterol Level(6 months)
- Change in LDL Cholesterol Level(6 months)
- Change in Red Blood Cell Count(6 months)
- Change in Hematocrit(6 months)
- Change in Hemoglobin Level(6 months)
- Change in White Blood Cell Count(6 months)
- Change in Blood Glucose(6 months)
- Change in High-Sensitivity C-Reactive Protein(6 months)
- Change in Aspartate Aminotransferase(6 months)
- Change in Alanine Aminotransferase(6 months)
- Change in Blood Urea Nitrogen(6 months)
- Change in Follicle-Stimulating Hormone(6 months)
- Change in Albumin(6 months)