CTRI/2025/06/089641尚未招募不适用
Evaluation of the Impact of Ayurvedic Formulation Livogrit on Quality of Life in Patients with Non-Alcoholic Fatty Liver Disease Prospective open label single arm observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 91
- 试验地点
- 3
- 主要终点
- Changes in the Chronic Liver Disease Questionnaire for NAFLD NASH
研究概览
简要总结
This is a single arm, open label, prospective, observational study evaluating the effectiveness of Livogrit in Subjects with Non alcoholic fatty liver disease (NAFLD). Data will be collected from three study sites and subjects will be followed up for next 90 days. The Chronic Liver Disease Questionnaire NAFLD NASH will be used to evaluate the quality of life and the effectiveness will be assessed by Liver function test after 90 days.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Established case of NAFLD (Grade I & II).
- •The subject is able and willing to provide consent.
排除标准
- •Alcohol associated liver disease (ALD) engage in heavy drinking about 4 or more drinks per day (56g) or 8 (112 g) or more drinks per week for women and 5 or more drinks per day (70 g) or 15 (210 g) or more drinks per week for men and other causes of liver disease.
- •Any dysfunction of liver besides non-alcoholic fatty liver disease like viral hepatitis liver parenchymal disease, ascites, portal hypertension, Hepato-cellular carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation.
- •Inability to attend follow-up session.
- •Pregnant, lactating women or pregnancy anticipated during study.
- •Diagnosed cases of Diabetes.
- •Thyroid disease not controlled by medication.
- •Uncontrolled Hypertension.
- •Patient on Anti-tubercular therapy.
- •Known cases of endocrine disorders including Cushing’s syndrome or history of long term steroid intake or any other secondary causes of fatty liver.
- •Patients with complications of Metabolic syndrome like Cerebrovascular Accident Myocardial Infarction Chronic Kidney disease.
- •Patient not willing to give written informed consent.
结局指标
主要结局
Changes in the Chronic Liver Disease Questionnaire for NAFLD NASH
时间窗: baseline (Day 1) to Day 90
次要结局
- Changes in Liver Function Test (LFT)(baseline (Day 1) to Day 90)
研究者
研究点 (3)
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