NCT00931853已完成3 期
National Study, Phase III, Parallel, Double Blind, Placebo Comparative and Randomized to Evaluate the Therapeutic Efficacy and Tolerability of the Combination Naturetti® (Cassia Fistula + Senna Alexandrina Miller) in the Chronic Functional Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Measure of the chronic functional constipation symptoms based on the Rome III criteria
研究概览
简要总结
Primary Objective:
- To evaluate the clinical efficacy of Naturetti (jelly sugar free)
- To test medication on subjects who suffer chronic functional constipation in 30 days use.
Secondary Objectives:
- To demonstrate the clinical tolerability when daily used (repeated doses) of the components of the study drug. The components will be evaluated by the adverse events occurrence classified by possibly related, probably related and definitely related
- To demonstrate the clinical tolerability of the study medication by the continuous use during the second phase study
- To identify any adverse events related to the study drug
- To identify any drug interaction.
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
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SENNA + CASSIA (Naturetti)
Experimental
Daily administration (oral) of one spoon (5g) of Naturetti (SENNA+CASSIA) jelly sugar free at bedtime, during 30 days
干预措施: SENNA+CASSIA(Naturetti) (Drug)
结局指标
主要结局
Measure of the chronic functional constipation symptoms based on the Rome III criteria
时间窗: From the baseline to the end of the study (at 30 days)
次要结局
- Evaluation of the stool aspect based on the Bristol Stool Scale(From the baseline to the end of the study (at 30 days))
- Evaluation of the use of sene extract as rescue medication(From the baseline to the end of the study (at 30 days))
研究者
研究点 (1)
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