CTRI/2023/12/060881尚未招募不适用
Change in Muscle Mass with Nutritional Therapy in Cirrhotic Patients - A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- To investigate the Change in Muscle Mass
研究概览
简要总结
Sarcopenia is definedas muscle wasting (progressive and generalized loss of muscle mass) togetherwith a decline of muscle function (loss of strength or physical performance).Sarcopenia has been associated with poorer survival in patients with cirrhosis. Nutrition may very well have direct influence on sarcopenia and functional status.There is no study on nutritional management of patients with sarcopenia. We will perform a randomized controlled study to assess the effects of nutritional therapy on sarcopenia in patients of cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with Liver Cirrhosis Sarcopenia.
排除标准
- •Patients with hepatic encephalopathy (grade≥ II according to the WestHaven Grading System).
- •Uncontrolled esophageal varices bleeding.
- •Refractory ascites.
- •Malignancy.
- •Patients with HPS or Portopulmonary Syndrome Severe renal dysfunction (estimated glomerular filtration rate< 30 ml/min/1.73 m2).
- •Severe cardiac disease, history of gastrectomy.
- •Patients with Neurological Disorders Previous poor compliance with pharmacologic treatment or nutritional counseling before initiating the trial supplement.
- •Patients with a history of hepatocellular carcinoma.
结局指标
主要结局
To investigate the Change in Muscle Mass
时间窗: 0,1,3 & 6 months
次要结局
- Improvement in albumin level, anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip)(Improvement in CTP & MELD score.)
研究者
研究点 (1)
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