Clinical study to assess the effectiveness of an investigational product in improving the health status of subjects in Improving the Liver Function including Non-Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The present clinical study is designed to evaluate the effectiveness, safety, and tolerability of a hepatoprotective investigational product containing a patented herbal complex in subjects with NAFLD. The study aims to comprehensively assess improvements in liver health through radiological, biochemical, metabolic, and symptomatic parameters. Key evaluations include changes in NAFLD fibrosis score, liver steatosis grading on ultrasound, and liver function markers such as AST, ALT, ALP, GGT, and bilirubin. Secondary assessments will include changes in metabolic indicators (insulin, fasting glucose, HbA1c, HOMA-IR), lipid profile, body weight, BMI, waist circumference, and relief from NAFLD-associated symptoms such as abdominal pain, nausea, loss of appetite, fatigue, itchy skin, and jaundice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (age 18 to 60) of either sex with BMI greater than 25.00 and less than, equal to 32.00 kgerm
- •Confirmed Diagnosis of NAFLD established by imaging (ultrasound/Fibroscan, CT scan or MRI), within 3 months of the screening phase.
- •The diagnosis of NAFLD is made according to the American Association for the Study of Liver Diseases (AASLD) criteria defined as complying following- a) There is hepatic steatosis by imaging or histology, b) There is no significant alcohol consumption, c) There are no competing aetiologies for hepatic steatosis, d) There are no co-existing causes for chronic liver disease.
- •Liver Steatosis Grade I, II, and III along with hepatomegaly by USG abdomen pelvis/Fibroscan at screening,.
排除标准
- •Regular or excessive use of alcohol within 2 years prior to initial screening.
- •Subjects with uncontrolled diabetes and changed medication in the past 3 months.
- •Presence of alternative causes of fatty liver 4) Weight loss morethan10% in the 6 months before the Screening Visit.
- •History of myopathies or evidence of active muscle disease.
研究者
Dr SIMADRI BHUSAN NAYAK
Government Ayurvedic College Balangir