A Prospective, Interventional, Randomized, Double-blind, Placebo-controlled, Clinical study to evaluate the Efficacy and Safety of Clearstone syrup (sugar free) in Patients with Asymptomatic Renal calculi.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of expulsion and change in size and density of renal calculi assessed by CT scan
研究概览
简要总结
STUDY TITLE: A Prospective, Interventional, Randomized, Double Blind, Placebo-controlled Clinical study to evaluate Efficacy and Safety of Clearstone syrup (sugar free) in patients with Asymptomatic Renal calculi.
Objective:
Primary objective
To evaluate the efficacy ofClearstone syrup (sugar free) in patients with Asymptomatic Renal calculi.
Secondary objective
To evaluate the safety ofClearstone syrup (sugar free) in patients with Asymptomatic Renal calculi.
End points:
| Primary Endpoints |
Evaluation of expulsion and change in size and density of renal calculi assessed by CT scan from baseline (Day 1) to EOT.
Secondary Endpoints
1. Evaluation of change in pain intensity by using Visual analog scale (VAS) from baseline (Day 1) to EOT .
-
Evaluate the tolerability of investigational product from baseline (Day 1) to EOT.
-
Assessment of rate of incidence of AEs and SAEs.
**Number of subjects:**A total of 100 participants will be randomized in 1:1 proportion as 50:50 participants in each arm (Clearstone syrup and Placebo respectively)
Study Duration: 17 weeks (16 weeks of treatment duration and 1 week follow up after treatment.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female patients aged 18-70 years with a diagnosis of renal stone size upto 10mm confirmed by non-contrast computerized tomography (CT) scan.
- •Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •Female participants of child bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at check-in.
- •Male participants with female partners of child-bearing potential must agree to abstinenceif this is in line with the usual lifestyle, or to use condoms plus partner use of an acceptable contraceptive for the duration of the study and until 4 weeks after dosing with the study drug.
- •Patients will to cooperate and give consent for the trial and comes for regular follow up.
排除标准
- •Patients with complications and requiring surgical interventions.
- •Patients with high values of serum creatinine, serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase, alkaline phosphatase and HbA1c at screening.
- •Any systemic disease requiring other medications of surgery for calculus condition.
- •Complicated cases of Renal calculi requiring surgical condition.
- •Chronic or current infectious diseases such as but not limited to chronic renal infection, Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris , myocardial infarction.
结局指标
主要结局
Evaluation of expulsion and change in size and density of renal calculi assessed by CT scan
时间窗: Baseline(Day 1) to EOT
次要结局
- 1.Evaluation of change in pain intensity by visual analog scale (VAS)(2. Evaluate the tolerability of IP.)
研究者
Dr Vipul Jaiswal
Saikrupa Hospital