A Prospective, Single-Center, Open-Labelled Study To Evaluate The Safety And Efficacy Of Lithobin Tablets In Patients With Renal Calculi
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the size or absence of kidney stones from baseline to Day 120
研究概览
简要总结
This study is an open-labelled, single-arm, prospective clinical study to evaluate the safety and efficacy of Tab. Lithobin therapy in patients diagnosed with renal calculi.
It is planned to screen and enrol a total of 30 patients for this study. Subjects who will provide assigned informed consent will be evaluated for the inclusion and exclusion criteria. Male and Female subjects aged between 18 and 75 years diagnosed with renal calculi will be enrolled in to this study.
Subjects will receive Tab. Lithobin - 2 tablets twice times daily for 120 days (4 months).
Primary Objective
1. To evaluate the efficacy of Tab. Lithobin in subjects diagnosed with renal calculi over a period of 4 months
Secondary Objective
1. To evaluate the safety of Tab. Lithobin treatment in subjects diagnosed renal calculi
2. To evaluate the dependence on analgesics for pain management during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Age 18-75 years (Both inclusive) 2 Patients with Renal calculi, diagnosis confirmed by plain X-Ray KUB 3 Size of the calculi ranging from 04 mm < 1.5 2cm 4 Able and willing to give written informed consent and comply with the requirements of the study protocol 5 Patients of reproductive potential (males and females) and willing to use a reliable means of contraception.
排除标准
- •1 Complicated cases of Renal Calculi requiring surgical intervention, any condition chronic or current infectious disease such as but not limited to chronic renal infection including active urinary tract infection.
- •2 Subjects is presenting with symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI) 3 Any other known urogenital disorders.
- •4 Subjects on herbal supplements for renal stone disease (plant extracts preparations or herbal medicines etc.) within previous 3 months.
- •5 Pregnant or breast feeding 6 Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation 7 Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline Patients with psychiatric illness or other condition that would limit compliance with study requirements 8 Actively participating in in other clinical trial or has participated in a clinical trial within the last 30 days.
- •9 Unwilling/unable to sign the informed consent 10 Any condition in the opinion of the investigator that may compromise the safety of the patient by participating in this study.
结局指标
主要结局
Reduction in the size or absence of kidney stones from baseline to Day 120
时间窗: 4 months
次要结局
- Reduction in the size or absence of kidney stones from baseline to Day 30, 60, 90(To evaluate the safety parameters like LFT, RFT, Hematology, Biochemistry and vitals)