A Open label Clinical Study to Evaluate the Efficacy and Safety of URAL Tablet in Urolithiasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Dysuria, Nausea/vomiting, frequency of micturition, fever.
研究概览
简要总结
Renal Calculi is a common condition experienced by individuals across the world population. Renal calculi are also known as Urolithiasis and commonly called Kidney stones. Kidney stones are mainly composed of calcium salts, uric acid, cysteine, and struvite. Calcium oxalate and calcium phosphate are the most common types accounting for >80% of stones, followed by uric acid (8–10%) and cysteine, struvite in remainders.The main aim of the present study is to evaluate the safety and efficacy of URAL tablets inreduction in size of calculi deposits and recovery from the clinical signs and symptoms of renal calculi.This is a randomized, open labelled clinical study to evaluate efficacy and safety of URAL tablets in subjects with Urolithiasis.The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject with Urolithiasis as diagnosed by clinical with calculi measuring < 10mm.
- •Hematologic and Biochemical parameters within normal limits (Study specific parameters: calcium, uric acid cannot be more than 2 times upper limit of normal value).
- •Aged between ≥18 to ≤ 50 years.
- •Subjects willing to sign informed consent and follow the study procedure and instructions.
- •Subjects who are diagnosed of diabetes mellitus, whose blood glucose level is under good control with consumption of Anti-hyperglycemic medications and the Random Blood Sugar (RBS) reading is ≤ 200mg/dl during the screening period, can be included in the study.
排除标准
- •Subjects with severe obstructive uropathy, those with serious systemic medical disorder- uncontrolled hypertension and diabetes mellitus, other metabolic disorders, endocrinal disorders and cardiac illness.
- •The subjects not to have used any drugs, for at least 1 week prior to the study for concurrent illness with diabetes and Hypertension.
- •Subjects with a strong history of food or drug allergy of any kind.
结局指标
主要结局
Dysuria, Nausea/vomiting, frequency of micturition, fever.
时间窗: Day 1, Week 4, Week 8, Week 12
3. Improvement in laboratory parameters: Hematological, Serological, Urine,
时间窗: Day 1, Week 4, Week 8, Week 12
Radiological.
时间窗: Day 1, Week 4, Week 8, Week 12
1.Reduction in calculi deposit/kidney stone size
时间窗: Day 1, Week 4, Week 8, Week 12
2. Recovery in clinical symptoms and signs like Colicky pain at the loin, Hematuria,
时间窗: Day 1, Week 4, Week 8, Week 12
次要结局
- 1.Safety profile and overall compliance(2. Self-reported AEs & SAEs)