A Randomized Controlled Clinical trial to Study the Efficacy of Kadali Kwath in Comparison with Varunadi Kwath in the Management of Mutrashmari
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
- To study the effect of Kadali Kwath in comparison with Varunadi Kwath in the management of Mutrashmari/ Urolithiasis
研究概览
简要总结
TITLE- A Randomized Controlled Clinical Trial To Study The Efficacy Of Kadali Kwath In Comparison With Varunadi Kwath In The Management Of Mutrashmari
Null Hypothesis H0 – Kadali Kwath is as effective as Varunadi Kwath in the management of Mutrashmari
Alternate Hypothesis H1- Kadali Kwath is more effective than Varunadi Kwath in the management of Mutrashmari
Study design: Randomized controlled Clinical trial.
Inclusion Criteria : 1) Patients having signs and symptoms of Mutrashmari. 2) Urolith of size up to 12 mm. 3) Genders : Both Males and females 4) Patients between age group 18 to 60 years will be included. 5) Urolith seen in urinary tract as per USG.
Exclusion Criteria : 1) Seriously ill patients. 2) Obstructive uropathy leading to gross hydronephrosis, renal function impairment. 3) Pyonephrosis, 4) CA of urinary tract. 5) Gross hematuria.(Visible blood in the urine) 6) Having Urolith of size more than 12mm. 7) Pregnant and lactating women. 8) Patients with no symptoms of mutrashmari
Sample Size -Total 70 (35 For each Group)
Patients coming in IPD And OPD of Shalyatantra department of research institute hospital and working hospital, with complaint of mutrashmari. Simple Randomized Sampling. (Lottery Method).
Group A – Kadali Kwath Group B – Varunadi Kwath Total duration of drug administration is 30 days. The mode of drug administration will be by oral route in the form of Liquid. Dietary support and oral hydrotherapy will be given in both groups. FOLLOW UP: Patient will be investigated on fifteenth & thirtieth day.
Results-Result will be drawn on the basis of criteria of assessment and Statistical Analysis.
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)（—）
入选标准
- •Patients having signs and symptoms of Mutrashmari.
- •Urolith of size up to 12 mm.
- •Genders : Both Males and females 4) Patients between age group 18 to 60 years will be included.
- •Urolith seen in urinary tract as per USG.
排除标准
- •Seriously ill patients.
- •Obstructive uropathy leading to gross hydronephrosis, renal function impairment.
- •Pyonephrosis, 4) CA of urinary tract.
- •Gross hematuria.(Visible blood in the urine) 6) Having Urolith of size more than 12mm.
- •Pregnant and lactating women.
- •Patients with no symptoms of mutrashmari.
结局指标
主要结局
To study the effect of Kadali Kwath in comparison with Varunadi Kwath in the management of Mutrashmari/ Urolithiasis
时间窗: Duration of treatment 30 days | Follow up on 15th and 30th days
次要结局
- To assess the effect of Kadali kwath in Mutrashmari( Renal and Ureteric stone) with expulsion of stone(Duration of treatment 30 days)