A Pharmaco clinical and Phytochemical study on SHARAPUNKHA(Tephrosia purpurea)in the management of early stage of Yakrutodara w.s.r to Nonalcoholic fatty liver disease
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- parameter for assessment of study outcome
研究概览
简要总结
Non alcoholic fatty liver disease is prevalent and concerning health condition characterized by accumulation of fat in the liver of individuals who consume little or no alcohol .Often associated with obesity ,poor diet and sedentary life style .NAFLD ranges from simple fatty liver more severe conditions like non alcoholic steatohepatitis (NASH) and cirrhosis .Numerous risk factors for the development of NAFLD have been explained .Most have some form of metabolic derangement or insulin resistance at the core of its pathophysiology .Estimate have been posited suggesting the incidence of NAFLD to be 20% -30% in western countries and 5% to 18% in Asia. In general Indian population the prevalence of NAFLD is estimated to be around 9% -32% ,with higher incidence rate among obese and diabetic patients .NAFLD is defined as the presence of hepatic steatosis with no evidence of hepatocellular injury in the form of ballooning of hepatocytes.
Description of yakrut related disease are minimum in ayurveda .The common disease is yakrutodara .Yakrut is an important organ in body ,it perform various function in the body .NAFLD can be considered as the early stage of yakrutodara where sama meda dhathu formation and its accumulation occur in yakrut .sedentary life style being one of the major factor in the pathogemesis of NAFLD .
The plant sharapunkha (Tephrosia purpurea) is highly branched ,herbaceous ,suberect,perennial herb , widely grown in india.The description of sharapunkha mainly seen in Nighandu period .Bhavaprakasha nighandu,Madanapala nighandu, etc. explained the medicinal properties of sharapunkha which mainly includes Ykrutrogahara ,pleeharoga hara etc. This study aimed to evaluate the efficacy of sharapunkha in the management of early stages yakrutodara with special reference to Non alcoholic fatty liver disease
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of either sex between the age of
- •70 years suffering from Non alcoholic fatty liver disease grade 1 and 2 0r Diagnosed case of NAFLD Grade 1 and 2 reporting to General OPD of Tibbia college hospital.
排除标准
- •1 Patient having H/O cardiovascular diseases and patient with uncontrolled HTN(BP being persistently above 140/90 mm Hg despite medication 2 Patient with uncontrolled diabetes and those who are on insulin therapy 3 pregnant and lactating patients 4 patients with communicable diseases like TB, varicella zoster etc 5 other hepatic pathologies (Eg-jaundice)or patient with elevated level of bilirubin etc.
结局指标
主要结局
parameter for assessment of study outcome
时间窗: 3 month
objective criteria includes LFT,USG,Fibroscan
时间窗: 3 month
Improvement in subjective criteria likes Fatigue,Pain in epigastrium,Anorexia,Nausea
时间窗: 3 month
次要结局
- Evaluating the safety of drug Sharapunkha(Tephrosia purpurea) which will be assessed with KFT(After 15 the day of trail and completion of trail ie 3 month)
研究者
JISHNU TK
Ayurveda and Unani tibbia college