Management of Urolithiasis with Pashanabhedadi Kwatha and Trikantakadi Kwatha- A comparative clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ultrasonography of abdomen and pelvis to detect the presence of calculi, size of calculi and number of number of calculi
研究概览
简要总结
Urolithiasis is formation of urinary calculi at any level of the urinary tract. It is estimated that approximately 2% of the population experiences renal stone disease in their life with male-female ratio 2:1. The peak incidence is observed in 2nd to 3rd decades. Renal calculi are characterized clinically by colicky pain (renal colic) as they pass down along the ureter and may be manifested by hematuria. The most common symptom is colicky pain often associated with macroscopic or microscopic hematuria. The severity of pain may also depend up on the site of occurrence of stone. The pain in urolithiasis is usually severe in nature especially if the stones are moving down to the ureter. Urinary calculi is considered to be the most common and important cause of obstructive uropathy. It also acts as an added risk factor for so many other conditions like Urinary tract infections, Chronic kidney diseases and Hypertension. Urolithiasis is such a disease which is having the maximum chance of reoccurrence and repeatedly undergoing the surgery or any other stone removal technique may adversely affect the whole urogenital system. So if we can manage the condition with oral medication which is explained in Ayurveda classics will be more beneficial for the society. With this intention we have selected the comparative study to evaluate the efficacy of Pashanabhedadi kwatha and Trikantakadi kwatha over subjective and objective parameters of Urolithiasis.
The study will be randomized open clinical trial having 2 groups with 50 subjects in each group and the medicine given will be in kashaya form with 96 ml dosage before food 2 times in a day.
Null hypothesis:
There is no significant difference in the efficacy of managing Urolithiasis between 2 groups. (Group 1 and 2)
Alternate hypothesis:
There is significant difference in managing urolithiasis between group 1 and group 2 favoring one group over the other in reducing the signs and symptoms of urolithiasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who have signed informed consent and having urolithiasis with stone size up to 10 ml will be included in the study.
排除标准
- •Subjects with chronic kidney disease, gross hydronephrosis, severe haematuria,stone size more than 10 mm and the subjects with gastritis will be excluded.
结局指标
主要结局
Ultrasonography of abdomen and pelvis to detect the presence of calculi, size of calculi and number of number of calculi
时间窗: Ultrasonography of abdomen and pelvis will be done on 0th day 60th day
次要结局
- Subjective symptoms like pain,burning micturition, dysuria,hematuria,frequency of micturition will be assessed based on the grading in severity of the symptom.(0th day,20th day,40th day,60th day)