An Open Label Single Arm Clinical Study To Evaluate The Combined Effect of Virechana And Trayantyadi Kashaya In Alcoholic Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the LFT Values
研究概览
简要总结
Alcoholic associated Liver Disease (ALD) comprise a spectrum of diseases associated with chronic Alcohol consumption ranging from Alcohol associated Fatty Liver Disease and Steatohepatitis (Alcoholic Hepatitis) to move advanced liver diseases including from fibrosis to cirrhosis.A high daily intake of Alcohol (>60g) in males and (>20 g) in females taken for more than 6 to 8 years, significantly increases the risk of ALD Alcoholic Fatty Liver is the earliest change and is almost universally present in heavy alcoholics. Among the Alcoholic Fatty Liver, 34.3% may end up with Cirrhosis. It is generally a benign condition with abstinence . Alcoholic Hepatitis occurs in 10% to 35% of heavy drinkers who develop necro inflammation with or without fat infiltration. Virechana is the first line of management for Pitta, Pittakapha, and Pittashayagata vikara.Trayantyadi Kashaya include Trayanti as one of the main ingredient which is directly indicated in Yakrit Vikaras as mentioned in Priyanighantu.
So present study an effort has been put forth to evaluate efficacy of Virechana and Trayantyadi Kashaya in Alcoholic liver disease.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.subjects having Alcohol dependence 1 year or more 2.Subjects full filling the diagnostic criteria 3.Subjects with or with out raised billirubin levl (0.1-10 mg/dl ) 4.Subjects not suffering from Alcoholic withdrawal symptoms 5.Subjects between the age group of 20-60 years irrespective of gender 6.Subjects with elevated LFT values.
排除标准
- •1.Subjects diagnosed with HIV, HBV, Tuberculosis, Myocardial infarction, other systemic diseases which interfere with the course of treatment.
- •2.Subjects diagnosed with Cirrhosis of liver, Ascites, Viral hepatitis, Severe Alcoholic Hepatitis, and other Psychiatric diseases which interfere with the course of treatment.
- •3.Subjects diagnosed with other Psychoactive drug dependance.
- •4.Subjects under active administration of hepato-toxic drugs.
- •5.Pregnant Women and Lactating Mothers.
- •6.Subjects not fit for Virechana.
结局指标
主要结局
Reduction in the LFT Values
时间窗: Pre-test: 0th day. | Post-test- After treatment: (Shamanaushadhi)
次要结局
- Changes in the Ultrasound of Abdomen(Pre-test: 0th day.)