An Interventional Study To Evaluate The Effectiveness Of Epigaea Repens In Cases Of Urolithiasis
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- According to the scores obtained (pre and post treatment) from the Urolithiasis Symptom Scoring (USS) method
研究概览
简要总结
This study is a non- randomized, open-label, single arm, uni-centre interventional study to evaluate the effectiveness of Epigaea Repens in cases of urolithiasis. The study will evaluate the extent of improvement in clinical symptoms due to renal calculi using Urolithiasis symptoms score (USS) as an assessment scale in cases of urolithiasis with Epigaea Repens and will also ascertain the clinical proved symptoms of Epigaea Repens if any. The primary outcome measures will be according to the scores obtained (pre and post treatment) from the USS scoring method. The secondary outcome measures will be to verify the clinical symptoms of Epigaea Repens.
Null Hypothesis (H0) - Epigaea Repens is not effective in cases of urolithiasis.
Alternate Hypothesis (H1) - Epigaea Repens is effective in cases of urolithiasis.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients giving consent for the study
- •Patients willing to have X-ray or USG (KUB) before and after treatment
- •Cases (symptomatic and asymptomatic) with radiological evidence (Ultrasound Whole Abdomen) of renal stone.
- •No history of expulsion of calculi after the radiological investigations within one month period
- •Patients having any urinary symptoms due to renal stone
- •Only those cases will be selected which will be having symptom similarity with the medicine Epigaea Repens.
排除标准
- •Females who want to conceive, are pregnant or lactating
- •Patients diagnosed with Chronic Kidney Disease, Nephrotic Syndrome
- •Cases of Hydronephrosis above grade II
- •Known cases of any other severe systemic disorders
- •Patient pursuing other treatment and are not willing to leave it
- •Gross developmental defects or structural abnormality of kidney.
结局指标
主要结局
According to the scores obtained (pre and post treatment) from the Urolithiasis Symptom Scoring (USS) method
时间窗: Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of 12 weeks using | Urolithiasis Symptom Scoring (USS) method
次要结局
- To verify the symptoms of Epigaea Repens in cases of Urolithiasis(12 months)