NCT00509418已完成3 期
Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).
研究概览
简要总结
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
- •Age between 18 and 70 years
- •Ability to provide informed consent
- •Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)
排除标准
- •Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
- •Pregnancy or lactation
- •Decompensated cirrhosis
- •Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
- •Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
- •Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter)
- •Contraindication to liver biopsy
- •Refusal to participate in the study
- •Concomitant disease with reduced life expectancy
- •Severe psychiatric conditions
- •Drug dependence
结局指标
主要结局
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).
时间窗: 24 weeks
次要结局
- Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment)(24 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.Chronic Hepatitis CCirrhosisNCT00502086Catalysis SL100
已完成
3 期
Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's DiseaseParkinson's DiseaseNCT01016470Catalysis SL100
暂停
3 期
Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis TreatmentChronic Inflammatory SyndromeNCT00978224Catalysis SL152
已完成
2 期
Viusid in Adults With Acute Fever of Viral EtiologyAcute Fever of Viral EtiologyNCT01008007Catalysis SL200
已完成
2 期
Evaluation of Ocoxin-Viusid® in Advanced Pancreatic AdenocarcinomaAdenocarcinoma of the PancreasAdvanced CancerDigestive System NeoplasmsPancreatic NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic CancerEndocrine System DiseasesPancreatic DiseasesNCT03717298Catalysis SL30