A Prospective, open labelled, non randomized, phase II clinical trial on Kalladaippu kudineer in the management of Kalladaippu Noi( Urolithiasis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The outcome will be aimed at reducing clinical symptoms and calculi size ,will be considered as successful outcome of the treatment
研究概览
简要总结
This is A Prospective, openlabelled, non randomized, phase II clinical trial on Kalladaippu kudineer in the management of Kalladaippu noi (Urolithiasis).After authentication and purification of the Kalladaippu kudineer is prepared and administered at the dosage of 30-60ml (Twice a day orally) for 45 days known renal calculi Patients (40 (IP & OP )patients). The primary outcome will be determining the effectiveness of Kalladaippu kudineer in the management of Kalladaippu noi.The secondary outcome will be to collect various siddha literatures and modern science journals,to evaluate the clinical lithotriptic & diuretic pharmacological activities of trial drug,to Evaluate additional effects & Siddha parameters, Envagai thervugal changes in
Kalladaippu noi (Urolithiasis),to evaluate the safety profile for acute & sub acute toxicity of the trial drug,
to Perform Biochemical analysis and to Perform Usg Abdomen in selected cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Evidence of renal calculus,confirmed by using 2.Renal colicky pain 3.Haematuria 4.Oliguria 5.Dysuria 6.Nausea,vomiting.
排除标准
- •1.Chronic appendicitis 2.Pyelonephritis 3.Recurrent UTI 4.Chronic renal failure 5.Bilateral obstructive uropathy 6.Diabetes mellitus 7.Metabolic disorder like hyperthyroidism, hyperparathyroidism.
结局指标
主要结局
The outcome will be aimed at reducing clinical symptoms and calculi size ,will be considered as successful outcome of the treatment
时间窗: 45 days
次要结局
- 1.To collect various siddha and modern journals for literature review on KALLADAIPPU NOI(2.To evaluate the clinical lithotriptic and diuretic pharmacological activities of trail drug)
研究者
PANDEESWARAN J
Government Siddha Medical College, Palayamkottai