NCT00004654已完成3 期
Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
National Center for Research Resources (NCRR)0 个研究点目标入组 60 人开始时间: 1996年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia.
II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.
详细描述
PROTOCOL OUTLINE: This is a randomized study. One group of patients is treated with soy protein isolate for 12 weeks. The control group receives a placebo for 12 weeks.
Patients cross to the alternate group following a 4-week washout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hereditary hemorrhagic telangiectasia (HHT) with 2 of the following:
- •First-degree relative with HHT
- •History of recurrent epistaxis or gastrointestinal bleeding
- •Three or more skin telangiectasia
- •Migraine headache meeting International Headache Society criteria 3 or more times a month for more than 1 year
- •No pattern of daily headaches
- •No severe head trauma
- •No onset of headaches after 50 years of age
- •At least 1 month since migraine prophylaxis
- •At least 1 month since any of the following medications: Beta blockers; Calcium channel blockers; Divalproex sodium; Tricyclic antidepressants; Selective serotonin re-uptake inhibitors
- •Concurrent regular treatment for migraine and gastrointestinal hemorrhage allowed
- •Creatinine no greater than 2.5 g/dL
- •No allergy to soy
- •No pregnant women
- •No women with intent to become pregnant
排除标准
- 未提供
研究者
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