Clinical Evaluation of Shothankusha Ras in the Management of Kaphaja Shotha Vis-a-Vis Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms and arrest of progress of Chronic Kidney Disease with sustained reduction in abnormal kidney function tests to 50% baseline
研究概览
简要总结
A clinical trial is done to evaluate the efficacy of the Ayurvedic preparation Shothamkusha Ras in the mangement of Kaphaja Shotha vis - a- vis Chronic Kidney Disease and to validate scientifically the observations that would significantly improve the Renal Function. Shothamkusha Ras, a unique formula of Herbo- Minerals which has its reference from an authentic Ayurvedic Classical text Bhaishjya Ratnavali and is given Orally , 125 mg, twice a day for 60 days. The study would be conducted in India aimed to complete in 4 years and the trial time being 18 months. Primary outcome measures will be relief in signs and symptoms (Subjective Parameters) number of patients with sustained reduction in abnormal Kidney function tests to 50% of baseline , arrest of the progress of the disease into ESRD and prevention of Dialysis and Renal Transplant.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosed cases of CKD of stage I,II,III 2.Elevated Serum Creatinine levels 3.Elevated Blood urea levels 4.Chronic Glomerular Nephritis 5.Nephritic Syndrome.
排除标准
- •1.Obstructive Causes 2.Urinary Calculi 3.Enlarged prostrate 4.Multiple Myeloma 5.Vesico Urethral Reflux 6.Clinically Non Responding Cases.
结局指标
主要结局
Relief in signs and symptoms and arrest of progress of Chronic Kidney Disease with sustained reduction in abnormal kidney function tests to 50% baseline
时间窗: Relief in signs and symptoms expected in 60 days
次要结局
- Change in abnormal Serum Creatinine levels and Blood Urea Nitrogen and Parenchymal changes in Kidney through Ultrasonography