Comparative clinical study on the efficacy Of Ksharamladi Yoga and Yava Paneeya Kshara in the management of Pittashaya ashmari(cholelithiasis)
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the size of gall stones based on
研究概览
简要总结
An open label double arm randomized comparative clinical prospective study on the efficacy of ksharamladi yoga on pittashaya ashmari,cholelithiasis in a age group of 20-60 years for a period of 60days. During this study period, 40 patients will be recruited and divided into two groups, Group A (trial drug) patients will be administered ksharamladi yoga (10ml bd with water) and Group B (Control drug) patients will be administered yava paneeya kshara (500mg bd) for a period of 60days. clinical assessment will be done for both subjective and objective criteria on 1st,31st,67th day .Statistical analysis will be done through data obtained on 0 day(BT) AND 67th day(AT) .
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with any of the clinical features of cholelithiasis like localized pain in epigastrium,right hypochondrium,occasionally radiate to the right scapular tip,nausea,flatulent dyspepsia.
- •2.Asymptomatic cholelithiasis detected incidently in USG.
- •3.Subjects having gall stones aged between 20-60 years will be selected.
- •4.Subjects with stone size measuring upto 8mm.
排除标准
- •1.Subjects with cholelithiasis associated with complications like jaundice,cholecystitis,Acute and Chronic pancreatitis,Mirizzi syndrome,Empyema of gall bladder,Carcinoma of gall bladder.
- •2.Pregnant and lactating women.
- •3.Systemic disorders and conditions like uncontrolled Diabetes,Cardiovascular disorders,Liver failure,immune compromised conditions which interferes with the course of treatment and requiring surgical interventions.
结局指标
主要结局
Reduction in the size of gall stones based on
时间窗: Baseline,60 days
1.USG Abdomen and pelvis
时间窗: Baseline,60 days
次要结局
- Significant clinical relief in signs & symptoms of cholelithiasis like Localized pain in epigastrium, right hypochondrium, occasionally radiate to the right scapular tip, nausea, flatulent dyspepsia.
研究者
Dr Veekshitha
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan