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临床试验/NCT00967681
NCT00967681已完成3 期

Efficacy and Safety of Nutritional Supplement ONCOXIN in Patients With Breast Fibrocystic Disease

Catalysis SL2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
Catalysis SL
入组人数
200
试验地点
2
主要终点
The ultrasonographic improvement at 24 weeks (end of the treatment)

研究概览

简要总结

The purpose of the study is to evaluate whether Oncoxin, a nutritional supplement, improves the clinical and ultrasonographic results in comparison with placebo during 24 weeks of treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with clinical and ultrasonographic confirmation of breast fibrocystic disease.
  • Patients older than 20 years.
  • Female patients.
  • Informed consent.

排除标准

  • Presents of another disease not well controlled.
  • Pregnant women or lactating.
  • Patient which are receiving another products from other investigations trials.

结局指标

主要结局

The ultrasonographic improvement at 24 weeks (end of the treatment)

时间窗: 24 weeks

Adverse effects at 24 weeks (end of the treatment)

时间窗: 24 weeks

次要结局

  • Lesion size according clinical measurement at 24 weeks (end of the treatment)(24 weeks)
  • Pain according patient examination at 24 weeks (end of the treatment)(24 weeks)

研究者

发起方
Catalysis SL
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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