A Randomized Controlled Clinical Trial To Study The Effect Of Saileya In Mutrashmari With Special Reference To Renal Calculus.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1.Reduction in the size of stone evaluate by USG Abdomen and pelvis.
研究概览
简要总结
**TITLE -**A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF SAILEYA IN MUTRASHMARI WITH SPECIAL REFERENCE TO RENAL CALCULUS.
**INTRODUCTION -**Kidney stones primarily develop within the kidneys and pose a significant health concern, especially due to their high recurrence rate. Preventing their recurrence remains one of the major challenges in modern medicine. When nephrocalcinosis is present alongside nephrolithiasis, it can contribute to approximately 2–3% of all end-stage renal disease cases.
Ayurveda has played a vital role in the management of Mutrashmari. Acharya Sushruta has classified its treatment into two broad categories: surgical (Shastrakarma) and non-surgical or conservative (Anushastrakarma) methods.
Acharya Bhavprakash has mentioned Saileya in karpuradi varga in Bhavprakash. Saileya mentioned for treatment of Mutrashmari as abhyantar chikitsa hence efficacy of Saileya churna is being studied.
Although Shaileya Churna is traditionally mentioned in Ayurveda for the management of Mutrashmari (renal calculi), there is limited scientific evidence available to validate its efficacy through modern research methods. This study aims to fill that gap by evaluating the efficacy of Shaileya as a single drug in the management of renal calculi.
Vas Scale used for assessment of pain.
Investigation like 1. USG -Abdo pelvis (stone size in mm)- Before & After treatment. (In between If needed) 2. Urine routine and microscopic. 3. BSL-Random. will be done
**SAMPLE SIZE -**The total sample size for this study will be taken as 70. Saileya Churna Group A (trial group) and Abhaya Churna Group B(Control group) will be given patients. Trial and control drugs will be purchased from GMC certified pharmacy. Bothdrugs will be administered in Churma Form for 30 days. All SOP of Churna Vidhi will be strictly followed during and after treatment. Follow up will be done on day 0, day15 and day 30.
**Null Hypothesis:(H0)**Saileya churna is not effective in Mutrashmari with special reference to renal calculus.
**Alternate Hypothesis: (H1)**Saileya churna is effective in Mutrashmari with special reference to renal calculus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient having clinical sign and symptoms of Mutrashmari like dull pain at renal angle, anorexia, haematuria.
- •2.All patient age of 18 to 60 years group will be selected irrespective gender, occupation, caste and socioeconomic status.
- •3.Size of stone – 8 to 10 mm present in kidney.
- •4.Patient who will give written consent for treatment.
排除标准
- •1.Patient with medical conditions like DM, HTN, Chronic Hematuria.
- •Carcinoma, Hydronephrosis, Pyelonephritis, Congenital anomalies of kidney.
- •2.Size of stone above 10 mm.
- •3.Patient who are suffering from severe systemic disorder like renal failure and infectious disease.
- •4.PUJ and UVJ calculus if obstructed.
- •5.If patient with more than 20 RBC in urine.
结局指标
主要结局
1.Reduction in the size of stone evaluate by USG Abdomen and pelvis.
时间窗: 1. Assessment - Baseline and 30 Day | 2. Follow Up - 0 Day, 15 Day, 30 Day | 3. Post Follow up - 35 Day
2. Reduction in symptoms like Pain in Renal angle and Burning micturition assessed by VAS (Visual Analog Scale)
时间窗: 1. Assessment - Baseline and 30 Day | 2. Follow Up - 0 Day, 15 Day, 30 Day | 3. Post Follow up - 35 Day
次要结局
未报告次要终点
研究者
Dr Bhagyashri Prakash Sonawane
SMBT Ayurved College and Hospital