Randomized, placebo controlled, clinical study to assess the efficacy & safety of Liveril Forte Tabletin subjects with Non-Alcoholic Fatty Liver Disease.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1.NAFLD fibrosis score by calculation at screening and end of the study.
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is a condition in which fat builds up in liver. Nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH) are types of NAFLD. NASH, witnesses’ inflammation and liver damage, along with fatty liver. Liveril Forte tablet is an advanced formulation that contains high strength Silymarin along with select micronutrients and antioxidants. Silymarin in Liveril Forte acts as a hepato-protectant, and optimizes the function of the liver. This tablet for liver is composed of ’Super Six’ hepato-protectants that act synergistically to stimulate the production of hepatocytes and removal of toxins from the liver. The Liveril tablet is useful for detoxifying the liver, and maintaining its health. Silymarin is a potent natural antioxidant, prevents liver damage caused by free radicals. Silymarin increases the glutathione synthesis inside the liver cell. Silymarin helps in the production of new liver cells (by protein synthesis) to replace the damaged old ones.
Liveril forte tablet is a health supplement that helps to maintain healthy liver and for detoxification of liver. It is used for liver damage due to alcoholism, acute and chronic liver diseases, alcoholic fatty liver, detoxifying liver and high cholesterol. Natural antioxidants helps the liver to respond better against invading infections by neutralizing damage caused by free radicals (harmful chemicals).
medicinal benefits· Silymarin acts as hepato-protectant and improves liver functioning.
· Stimulates hepatocytes (liver cells) production and removal of toxins from liver.
· Prevents liver damage caused by free radicals (harmful chemicals) as it contains Silymarin, a potent natural antioxidant.
· Also, has potential of sensitizing production of new liver cells to replace damaged old ones.
The present research is an attempt of clinical validation of Liveril Forte Tablet in patients suffering from NAFLD. With the present research we can apply the knowledge from nutritional benefits along with the clinical trials to address important medical need of NAFLD patients to improve liver function and to control the disease progression. There is need to do primary translational work earliest & focus at some targeted aim and come up with a formulation for same to improve steatosis, hepatic inflammation and fibrosis, while ameliorating associated symptoms, insulin resistance, glucose metabolism, and obesity and to prevent progression to cirrhosis of the liver. Which could be achieved through the present research. We can utilize these outcomes to develop a strategy for treating NAFLD in more appropriate and assured way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults (age 18 to 60 years) both sex with BMI ≥25.00 and ≤32.00 kg/m2 2.Confirmed Diagnosis of NAFLD established by imaging (ultrasound, 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 (Chalasaniet al.2017) 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 etiologies for hepatic steatosis,(d) There are no co-existing causes for chronic liver disease;3.Liver steatosis grade I, II, and III by USG abdomen pelvis at screening Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations; 4.With or without deranged liver function test with serum AST or ALT more than 1.5 times than upper range of normal values.
排除标准
- •Regular or excessive use of alcohol within 2 years prior to initial screening;
- •Presence of alternative causes of fatty liver;
- •Weight loss >10% in the 6 months before the screening visit;
- •Use of drugs associated with NAFLD for more than 12 consecutive weeks in the 1 year before start of the study, including amiodarone, tamoxifen, methotrexate, systemic glucocorticoids, anabolic steroids, tetracycline, estrogens in doses higher than used in oral contraceptives, valproate, chloroquine, or antiretroviral drugs;
- •History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT) or listed for OLT;
- •History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis;
- •Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or imaging techniques;
- •Patients with unstable cardiovascular disease including, unstable angina, (i.e., new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of New York Heart Association class (III – IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months, uncontrolled hypertension (systolic BP>180 mmHg and/or diastolic BP >110 mmHg on two consecutive occasions), stroke or transient ischemic attack within the prior 6 months;
- •History of myopathies or evidence of active muscle disease;
- •History of malignancy in the past 5 years and/or active neoplasm;
- •Participation in any other therapeutic clinical study in the past 3 months, including participation in any other NAFLD clinical trials;
- •History of bladder disease and/or hematuria or has current hematuria except due to a urinary tract infection;
- •Illicit substance abuse within the past 12 months;
- •Pregnant/lactating female (including positive pregnancy test at the screening visit);
- •History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption).
结局指标
主要结局
1.NAFLD fibrosis score by calculation at screening and end of the study.
时间窗: Screening, Day 30, Day 60 and Day 90
3.Severity grading of symptoms such as abdominal pain, abdominal tenderness, nausea,loss of appetite, fatigue, itchy skin, jaundice on 4 point Linkert scale (None, mild, moderate and severe)
时间窗: Screening, Day 30, Day 60 and Day 90
2.Liver Steatosis Grade I, II, and III by USG abdomen pelvis at screening and end of the study.
时间窗: Screening, Day 30, Day 60 and Day 90
次要结局
- 1.Parameters of liver function test (LFT) like AST, ALT, ALP, GGT, bilirubin total, direct and indirect, albumin and globulin etc. at screening and end of the study.(2.Serum levels of insulin, fasting plasma blood sugar and HOMA-IR score.)