NCT00994851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
- 96
- 试验地点
- 1
- 主要终点
- Evaluation of the evacuation frequency during the treatment and follow-up period
研究概览
简要总结
Primary Objective:
To evaluate the clinical efficacy of Naturetti (capsules) , considering the following criteria:
- Evacuation frequency during the treatment and follow-up period
- Consistency of stools during the treatment and follow-up period
- Global evaluation, regarding increase in frequency of evacuation and shape of stools.
Secondary Objective:
- Number of days without evacuation
- Proportion of evacuation with pain
- Proportion of evacuation with strain
- Proportion of evacuation with incomplete sensation
- Proportion of blocked stools
- Proportion of manual maneuvers to facilitate defecation
- Proportion of subjects that adhere to the diet recommended
- Proportion of the patients who have to use rescue medication
- Level of constipation improvement, according to the patient evaluation
- To evaluate clinical tolerability of the study medication by the continuous use
- To evaluate the occurrence of 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SENNA+ CASSIA
Experimental
Daily administration (capsule) of Naturetti (SENNA+ CASSIA) at bedtime, during 30 days
干预措施: SENNA+CASSIA (Drug)
Placebo
Placebo Comparator
Daily administration (capsule) of placebo at bedtime, during 30 days
干预措施: placebo (Drug)
结局指标
主要结局
Evaluation of the evacuation frequency during the treatment and follow-up period
时间窗: 30 and 45 days
Evaluation of the stools consistency during the treatment and follow-up period
时间窗: 30 and 45 days
Global evaluation, regarding increase in frequency of evacuation and shape of stools
时间窗: 30 and 45 days
次要结局
- Number of days without evacuation(30 days)
- Proportion of evacuation with pain(30 days)
- Proportion of evacuation with strain(30 days)
- Proportion of evacuation with incomplete sensation(30 days)
- Proportion of blocked stools(30 days)
- Proportion of manual maneuvers to facilitate defecation(30 days)
- Proportion of subjects that adhere to the diet recommended(30 days)
- Proportion of the patients who have to use rescue medication(30 days)
- Level of constipation improvement, according to the patient evaluation(30 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile DysfunctionChronic Prostatitis With Chronic Pelvic Pain SyndromeErectile DysfunctionNCT06064448Xintian Pharmaceutical254
已完成
3 期
Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult SubjectsInfluenzaNCT00630331Novartis Vaccines11,404
已完成
1 期
A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the FaceEnlarged PoresSebum ProductionNCT05784363Merz North America, Inc.31
已完成
3 期
Fixed-Dose Trial in Early Parkinson's Disease (PD)Parkinson DiseaseNCT04201093AbbVie529
已完成
3 期
An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and VomitingChemotherapy-Induced Nausea and VomitingNCT01339260Helsinn Healthcare SA1,455
