A Prospective Open labelled non randomized phase II Clinical trial on Karasoodasathu Parpam in management of kalladaippu noi(Urolithiasis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Reduction in Severity of renal colicky pain,Nausea,Vomiting,Haematuria,Dysuria,Oliguria
研究概览
简要总结
The study is a Prospective Open Labelled Phase II non-randomized clinical study to evaluate the therapeutic efficacy of Karasoodasathu Parpam in the management of Kalladaippu Noi(Urolithiasis).The trial drug will be administered at the dose of 2.5 - 5mgKgBWTwice a day|AF for 45 days in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital ,Palayamkottai,Tirunelveli,Tamilnadu.The primary outcome will be the evaluation of therapeutic efficacy of trial drug Karasoodasathu parpam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Renal colicky pain from loin to groin 2.Nausea and Vomiting 3.Haemeturia 4.Oliguria 5.Dysuria 6.Patients who are willing to undergo radiological Investigations and give blood for laboratory investigations.
排除标准
- •1.Chronic Appendicitis 2.Cholecystitis 3.Pyelonephritis 4.Recurrent UTI 5.Diabetes mellitus 6.Metabolic disorders like Hyperthyroidism,Hyperparathyroidism 7.Pelvic inflammatory disease 8.Chronic Renal Failure.
结局指标
主要结局
1.Reduction in Severity of renal colicky pain,Nausea,Vomiting,Haematuria,Dysuria,Oliguria
时间窗: 45 days
2.Reduction in size of the kidney stone in USG Abdomen and pelvis(In selective patients)
时间窗: 45 days
次要结局
- 1.Evaluation of pharmacological ,Biochemical and Phytochemical analysis of trial drug.(2.Determination of safety profile of trial drug)