Evaluating Clinical Efficacy Of Add On Effect Of Basti In Non-Alcoholic Fatty Liver Disease Based On Sonographic Findings.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes In Sonography Findings (Expecting From Grade II To Grade I Or 0 And From Grade I To Grade 0) Along With Changes In Clinical Presentations (Expecting 5% To 10% Reductions In Signs And Symptoms).
研究概览
简要总结
Nonalcoholic Fatty Liver Disease, A Metabolic Disorder Of Hepatic Origin, Is Increasingly Common Worldwide. NAFLD Is A Wide Spectrum Of Diseases Characterized By Fatty Infiltration Of The Liver, Simple Steatosis, Steatohepatitis, Advance Fibrosis And Cirrhosis.Iit Is A Condition Where Excess Fat Gets Accumulates In The Liver Cells In Individuals Having No Significant History Of Alcohol Consumptionii. The Main Cause Of NAFLD Is Imbalance Between Rate Of Import / Synthesis And Rate Of Export /Catabolism Of Fatty Acid In Liver Or Reduced Synthesis Of VLDL & Increased Hepatic Triglycerides Synthesis Due To Decreased Oxidation Of Fatty Acid Or Increased Free Fatty Acid Being Delivered To The Live.
PRIMARY OBJECTIVES
1. To Evaluate The Clinical Efficacy Of BastiIn Reducing The Liver Fat Deposition In NAFLD.
SECONDARY OBJECTIVES
1. To Prevent The Progression And Complication Of The Disease.
2. To Understand The Relation (Correlation Coefficient) * Between Vitamin D And NAFLD (Grade I &II).
3. To Understand The Significance Of Fatty Liver Index For Diagnosing NAFLD In Non-Diabetic And Non- Metabolic Syndrome Associated NAFLD Patients.
4. To Improve The Quality Of Life In The Patients Of NAFLD.
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
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Previously diagnosed and newly diagnosed case of NAFLD (fatty liver grade 1 or 2) confirmed by Sonography (USG Or Fibroscan) 2.Grade 1 & Grade 2 NAFLD in USG Or F0 to F2 Less Than 10kPa Score,CAP Score -S1 248-260db per m,S2 260-290 db per m,IQR per M-30 Percent or less in Fibroscan.
- •3.Patients willing to participate in the clinical trial.
排除标准
- •1.Patent having NASH/NAFLD associated with Metabolic diseases
- •Patients having NAFLD Grade 3 Or More
- •Patients with Type 2 diabetes
- •Known case of Hypertension
- •Known case of hypothyroidism or hyperthyroidism
- •Patients having BMI Greater than 30,
- •Patients having deranged liver functions (AST per ALT Greater than 2 folds).
- •Patients suffering from Hepatitis, Cirrhosis of liver, Ascites, Portal hypertension (PTH), patient having other chronic liver diseases, etc.
- •Patients having deranged renal functions Or chronic kidney diseases.
- •Patients suffering from AIDS, Tuberculosis and other infectious diseases.
- •Any Malignancy.
- •Pregnant and lactating women.
- •Patient on long term medication (Hepatotoxic medication like NSAID, Rifampicin,steroid).
- •Patients consuming Alcohol or other narcotic substance.
结局指标
主要结局
Changes In Sonography Findings (Expecting From Grade II To Grade I Or 0 And From Grade I To Grade 0) Along With Changes In Clinical Presentations (Expecting 5% To 10% Reductions In Signs And Symptoms).
时间窗: Day 1 | 30 Days | 60 Days
次要结局
- 1 Changes In Waist Circumference(2 Changes In Liver Function Tests)
研究者
Dr Kachchhi Gopi Ashvinbhai
All India Institute Of Ayurveda