NCT01408849终止2 期
Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- SODA score
研究概览
简要总结
This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA score, secondary endpoint is endoscopic classification (Sydney).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •being literate
- •diagnosis of dyspepsia
- •initial SODA score > or = 25
排除标准
- •pregnancy
- •lactation
- •allergy to Maytenus species
- •fail to use the drug for 3 uninterrupted weeks
- •new onset serious adverse events, attributable to the drug
- •patient's request
研究组 & 干预措施
Maytenus
Experimental
Tea of Martens ilicifolia leaves
干预措施: Maytenus ilicifolia leaves infusion (Drug)
Omeprazole
Active Comparator
Omeprazole as active comparator
干预措施: Omeprazole (Drug)
结局指标
主要结局
SODA score
时间窗: 8 weeks
次要结局
- Sydney classification(8 weeks)
研究者
Fabio Carmona
Assistant Professor
University of Sao Paulo
研究点 (1)
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