Silymarin in NAFLD
关键词
抽象
描述
In this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, nephrologists or family physicians in the Department of Gastroenterology and Department of Nephrology, dialysis and kidney transplantation KBC Rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP) for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis. In all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease.
This study will include 350 patients. Taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. Patients will be randomized into two groups. The first group will be consisted of the patients with NAFLD who will be receiving Verum therapy during the 6 month period. The second group will be consisted of the patients with NAFLD who will be receiving placebo during the 6 months period, which will be identical to the Verum preparation in its packaging and form.
After the 6 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose), as well as the TE-CAP in order to evaluate the efficiency of Silymarin for the treatment of NAFLD.
日期
最后验证: | 09/30/2019 |
首次提交: | 11/03/2016 |
提交的预估入学人数: | 11/20/2016 |
首次发布: | 11/24/2016 |
上次提交的更新: | 10/25/2019 |
最近更新发布: | 10/28/2019 |
实际学习开始日期: | 09/19/2019 |
预计主要完成日期: | 11/30/2020 |
预计完成日期: | 06/29/2021 |
状况或疾病
干预/治疗
Drug: Group Silymarin
Other: Group Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Group Silymarin Silymarin 2x200 mg 8 weeks (2x2 caps) Silymarin 2x100 mg 16 weeks (2x1 caps) | Drug: Group Silymarin Capsules contains 100 mg of silymarin |
Placebo Comparator: Group Placebo 2x2 placebo caps 8 weeks 2x1 placebo caps 16 weeks | Other: Group Placebo Capsule will be identical in shape, size and color, packed in the same way like verum |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - NAFLD patients - signed informed consent - possibility to follow instruction and the protocol Exclusion Criteria: - chronic B or C hepatitis - usage of hepatotoxic drugs in the period of 6 months before inclusion - chronic kidney insufficiency (grade 4 and 5), hemodialysis - any other chronic liver disease - opioid dependancy - any malignancy - HIV seropositivity - alcohol abuse - pregnancy - inability to follow the protocol |
结果
主要结果指标
1. Change (Reduction) of parameters of liver steatosis defined by CAP (Controlled Attenuation Parameter) and liver fibrosis defined by LSM (liver stiffness measurements) during the 6 months period [0 week (Initiation) and during 24-25 week (End of the Study)]
次要成果指标
1. Change in liver enzymes in period of 6 months [0 week (Initiation) and during 24-25 week (End of the Study)]
2. Change in insulin resistance in period of 6 months [0 week (Initiation) and during 24-25 week (End of the Study)]
3. Change in lipidogram in period of 6 months [0 week (Initiation) and during 24-25 week (End of the Study)]