Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom) on the Nutritional State and Liver Biochemistry in Hepatitis C Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Measure: influence of Agaricus blazei (Murrill) ss. Heinemann on the evolution of nutritional state and liver function in hepatitis C patients. Time Frame: six months
研究概览
简要总结
The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.
详细描述
Ten patients were studied (5 - GI - not taking A. blazei - and 5 - G2 - taking A. blazei), from both sexes, with positive Anti-VHC and a healthy nutritional state, admitted into in the viral hepatitis ward. Diagnosis and treatment for hepatitis C concurred with the regulations of the Ministry of Health and nutritional evaluation was performed in 3 moments according to anthropometrical, bioimpedance, biochemical and dietary standards, with duration of 6 months. The consumption of A. blazei (10g/day) in dehydrated powder was concomitant with antiviral therapy (conventional or pegylated interferon associated with ribavirin) with duration of 5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have been informed and signed adequately the free and clarified assent
- •Initiating the anti-viral treatment (interferon or pegylated interferon associate the ribavirin)
- •Age: 24-70 years
- •Gender :both the gender
- •Race : all races
- •To present serology positive to the anti-VHC ELISA
- •To present genotype type 1,2,or 3
- •Body mass index- >18,5 e < 35kg /m2
- •Conditions full to the ORAL ingestion
排除标准
- •Don't agree to the project or don't have signed the term of clarified free assent
- •Restriction for oral ingestion
- •The existence of surface of antigen of the hepatitis B virus(Ag HBs)
- •The existence of antibody for the human immunodeficiency virus
- •To be enclosed in another project of research or form of treatment
- •Pregnant women
- •Cirrhosis
- •Patients with hepatitis auto-imune.
研究组 & 干预措施
G1
G2
干预措施: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom) (Dietary Supplement)
结局指标
主要结局
Measure: influence of Agaricus blazei (Murrill) ss. Heinemann on the evolution of nutritional state and liver function in hepatitis C patients. Time Frame: six months
时间窗: Time Frame: six months
次要结局
未报告次要终点