A Comparative Study to Evaluate the Efficacy of Patolamuladi Kwatha followed by Navasadara and Badarashma in the Management of Cholelithiasis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Size Reduction of Cholelithiasis
研究概览
简要总结
Gallstones are the most prevalent issue affecting the biliary system. They impact around 10-15% of the world population, approximately 4% in Indiawith over 80% of those affected experiencing symptoms at some point in their lives, and 1-2% requiring surgery annually. Among them males affected are 6.2% and females are at 7.3%. Asymptomatic gallstones will be monitored, while surgery (cholecystectomy) is reserved for symptomatic cases or those with complications. Ashmari (caliculi) in Ayurveda mainly focuses on urinary stones with the classification of Dosha predominancy. Pittaja Ashmari pathogenesis can be considered here. Ashmari Bhedana Dravyas (Litholytic and Lithotripsic drugs) have been explained in many Samhitas, Nighantus and Rasa Granthas. Considering the risk of complications by cholelithiasis, limited medical managements available in contemporary systems, necessity for evaluating, updating and validating the ayurvedic treatments; there is a high need for the present clinical study to evaluate the efficacy of Patolamuladi Kwatha followed by Navasadara and Badarashma in the Management of Cholelithiasis. The scientific research for the authentication of these easily available, cost effective and unique combination is highly needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects irrespective of sex, given consent from age group 18 to 60 years Asymptomatic cases Mild symptomatic without any complications of cholelithiasis.
- •Subjects with sonographic evidence of gall stones of size less than 15mm diameter.
排除标准
- •Persons who are contraindicated for Paniya Kshara Immunocompromised persons uncontrolled systemic diseases like Diabetes mellitus HbA1C more than 8 percent Hypertension Complicated cases of Cholelithiasis like Cholecystitis Choledocholithiasis Cholangitis Hereditary haemolytic diseases leading to pigment stones Subjects with congenital anomalies of hepato biliary system Subjects with features of liver failure obstructive jaundice Carcinoma gall bladder acute obstructive cholecystitis Subjects suffering from other systemic disorders and condition which interfere with the treatment and requiring surgical intervention.
结局指标
主要结局
Size Reduction of Cholelithiasis
时间窗: 60 days
次要结局
- Reduction in the Number of stone and Sludge in the gallbladder(60 days)
研究者
DrAmruthagowriY
Rajiv Gandhi University of Health Sciences Bengaluru Karnataka
