Randomized Controlled Trial To Study The Efficacy of Madhu Mishrit Gokshurbeej Churna In The Management ofMutrashmari with Special Reference To Renal Calculus.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome is to evaluate the efficacy of Madhu Mishrit Gokshurbeej Churna with Ajaksheer in managing Mutrashmari (renal calculus) by assessing reduction in stone size and number (via USG), symptom relief (pain, burning micturition, nausea, vomiting, and tenderness), and changes in calculus location over a 7-day treatment period.
研究概览
简要总结
This randomized, open-label controlled clinical trial aims to compare the safety and efficacy of Madhumishrit Gokshurbeej Churna (3 grams) with Pashanbhed Churna (3 grams) over a 7-day period in 80 patients diagnosed with Mutrashmari (renal calculus). The primary objectives are to assess stone reduction, symptom relief, and stone passage, seeking a natural and cost-effective treatment alternative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age of patients above 18 years and below 60 years.
- •Patients are accepted irrespective of sex, occupation, religion and socio-economic status.
- •Patients presented with Samanya Lakshanas of Mutrashmari as per the classics – Pain at renal angle, Painful and frequency micturition, Burning micturition, Vomiting, Nausea.
- •Radiological evidence of calculus up to 6mm without any residual complications.
- •Patients who give informed consent and are willing to undergo treatment.
- •Patients who follow proper protocols should be included.
排除标准
- •Patients of known case of malignancy/ carcinoma of urinary tract.
- •Patients having Mutrashmari associated with 1)Diabetes mellitus 2)Acute renal failure 3)Chronic renal failure 4)Obstructive uropathy 5)Congenital abnormalities of urinary system 6)Prostatomegaly Immunocompromised Patients.
- •Patients who are not giving written consent are excluded.
- •Patients who withdraws treatment by themselves in between.
- •Patients who are not willing for treatment.
结局指标
主要结局
The primary outcome is to evaluate the efficacy of Madhu Mishrit Gokshurbeej Churna with Ajaksheer in managing Mutrashmari (renal calculus) by assessing reduction in stone size and number (via USG), symptom relief (pain, burning micturition, nausea, vomiting, and tenderness), and changes in calculus location over a 7-day treatment period.
时间窗: Day 0, 3 and 7
次要结局
- Secondary Outcomes(1.Effect of Gokshurbeej Churna on Ashmaribhedan (stone breaking) & Mutral (diuretic) action assessed via changes in urinary output, frequency of urination & relief in urinary obstruction.)