Clinical Evaluation of Abhayadi Kwatha in the Management of Non Alcoholic Fatty Liver Disorder(NAFLD)-An Open Labelled Clinical Trial
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
- Reduction in the hematological parameters of LFT(Including ALT, AST, ALP, GGT, S. Bilirubin, PT, INR, Total protein and albumin) and changes in USG whole abdomen
研究概览
简要总结
Non-alcoholicfatty liver disease (NAFLD) is fat accumulation in the liver due to increasingsedentary lifestyles and changing dietary patterns. NAFLD includes spectrum of progressiveliver disease ranging from fatty infiltration alone (steatosis) to fattyinfiltration with inflammation (non-alcoholic steatohepatitis, NASH) and mayprogress to liver cirrhosis and primary liver cancer.
NAFLD isfrequently asymptomatic, although it may be associated with: Dyspepsia,Fatigue, Malaise, and Right upper quadrant discomfort.
NAFLD iscommonly diagnosed as incidental biochemical abnormality during routine bloodtests and during USG or CT Scan of the abdomen. No pharmacology agents arecurrently available for NAFLD, several Empirical treatment strategies such asdietary restriction, physical exercises and weight reduction forms the firstline of treatment. Hence there is search for alternative treatment modalitiesin other systems of medicine which is safe and cost effective.
DIAGNOSTIC CRITERIA:
The patient will be diagnosed based on Clinical features (Dyspepsia, Fatigue,Malaise, and Right upper quadrant discomfort.) and Radiological(USG)findings and laboratories investigations(LFT)
Dyspepsia includes Epigastric pain, Regurgitation, Nausea, Vomiting,Belching and Dysphagia
1. Ultrasonographyof abdomen which showsbright liver due to hyperechogenicity.
2. BLOODREPORTS: That includesLFT with mild to moderately elevated serumtransaminase (ALT:
AST) and nonspecific elevation ofgamma-glutamyl transferase.
Present study is being planned to evaluate the study on NAFLD with drug Abhayadi Kwatha . The sample size is 30 patients.Abhayadi Kwatha will be given in the dose of 40ml twice a day empty stomach
Study duration is 60 days. Study design is an Open Labelled Clinical Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex of age group, above 18 years and below 60 years.
- •Both freshly detected and previously diagnosed cases of NAFLD.
- •USG findings suggestive of NAFLD grade 1,2 and 3.
排除标准
- •Patient aged below 18 years and above 60 years.
- •Pregnant women and lactating women.
- •Uncontrolled Diabetes with (HBA1C greater than 7%) Complications of Metabolic Syndrome like Cardiovascular disease, MI, Chronic Kidney Disease.
- •Consuming Hepatotoxic drugs, Narcotic drugs and consuming Alcohol.
- •Cirrhosis, Ascites, Variceal Hemorrhage, Hepato-Renal Syndrome.
- •HIV, Malignancies, T.B. Patient with any acute or chronic systemic illness and with acute infectious or inflammatory conditions.
结局指标
主要结局
Reduction in the hematological parameters of LFT(Including ALT, AST, ALP, GGT, S. Bilirubin, PT, INR, Total protein and albumin) and changes in USG whole abdomen
时间窗: 60 days
次要结局
- Improvement in the symptoms of Non Alcoholic Fatty Liver Diseases(Day 15)