NCT00247026撤回1 期
A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- major hematologic improvement in any lineage
研究概览
简要总结
To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that are desirable in MDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDS patients with RA, RARS or RAEB will be eligible for treatment with CoQ10 as long as their IPSS score ≤ 1.5.
排除标准
- •Pregnant women and nursing women will be excluded.
- •History of clinically significant liver or kidney disease.
- •IPSS score >1.5
- •Poorly controlled diabetes mellitus, hypertension, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
结局指标
主要结局
major hematologic improvement in any lineage
次要结局
- Time to disease progression
- Overall and progression-free survival
- Cytogenetic response
研究者
研究点 (1)
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