Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Size of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged >65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.
- •Signed informed consent
排除标准
- •Previous surgical intervention for the treatment of cholelithiasis
- •Cholelithiasis with acute symptoms requiring emergency surgery
- •Cholelithiasis associated with neoplastic condition of any localization or origin
- •Usage of other antioxidants within the duration of the clinical trial
- •Handicap and/or psychiatric condition preventing treatment accomplishment
研究组 & 干预措施
Renalof
干预措施: Renalof (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Size of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)
时间窗: 6 month
Number of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)
时间窗: 6 month
次要结局
- Presence of digestive symptoms associated with cholelithiasis(6 month)
- Occurrence of adverse effects during treatment(6 month)