Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- decreased insulin resistance
研究概览
简要总结
This clinical study is designed to evaluate the safety of oral administration of the medical food Hoodia to patients with non alcoholic fatty liver disease.
Oral administration of Hoodia is common in many western world countries for appetite suppression and as a food supplement or medical food used for dietary purposes.
Nonalcoholic steatohepatitis or NASH is a common, often "silent" liver disease which affects about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This clinical trial has been designed to assess the safety of short term oral administration of Hoodia to patients with NASH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed the informed consent process culminating with written informed consent by the subject
- •Men and women age 18 to 65 years inclusive.
- •Patients with biopsy proven NASH with a score of 4 or above.
- •Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication 2 months prior to enrolment), impaired fasting glucose or impaired glucose tolerance.
- •HBA1C between 5.5 and 14%.
排除标准
- 未提供
研究组 & 干预措施
2
Patients receiving placebo
干预措施: Placebo (Other)
1
Patients receiving Hoodia
干预措施: Hoodia gordonii (Dietary Supplement)
结局指标
主要结局
decreased insulin resistance
时间窗: 30 days
safety
时间窗: 60 days
次要结局
- reduced hepatic injury(30 days)
- reduced weight/BMI/abdominal circumference(30 days)