NCT01634256已完成2 期
A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in ALT(Alanine Transaminase)
研究概览
简要总结
The investigators performed a double-blind parallel study in a group of showing mild hepatic injury subjects who were given Fermented turmeric over a period of 12 weeks. The investigators measured liver function parameters , including ALT(Alanine Transaminase), AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and serum bilirubin, and monitored their blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 19-70 years old
- •Mild hepatic injury as indicated by ALT(Alanine Transaminase) level ≥ 40
- •Able to give informed consent
排除标准
- •Allergy or hypersensitivity to any of the ingredients in the test products
- •History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •Carriers of viral hepatitis (type B and C)
- •History of underlying Esophageal varices, hepatic encephalopathy, ascites(past 12 months)
- •Participation in other clinical trials within the past 2 months
- •Patients with acute hepatitis (type B and C)
- •History of underlying cirrhosis and liver cancer
- •History of underlying biliary diseases such as jaundice or gallstones
- •History of underlying kidney disease such as Chronic renal failure or nephrotic syndrome
- •Pregnant, planning to become pregnant, or breast-feeding
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
Fermented turmeric
Experimental
干预措施: Fermented turmeric (Dietary Supplement)
结局指标
主要结局
Changes in ALT(Alanine Transaminase)
时间窗: 12 weeks
ALT was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Changes in AST(Aspartate Transaminase)(12 weeks)
- Changes in ALP(Alkaline Phosphatase)(12 weeks)
- Changes in γ-GT(Gamma-Glutamyl Transferase)(12 weeks)
- Changes in Serum Bilirubin(12 weeks)
研究者
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
研究点 (2)
Loading locations...
相似试验
终止
不适用
Moderato System: A Double-Blind Randomized Trial Ver 1.1Hypertension Resistant to Conventional TherapyBradycardiaAtrioventricular BlockNCT02837445BackBeat Medical Inc70
终止
不适用
Moderato System in Patients With HypertensionHypertension, Resistant to Conventional TherapyAtrioventricular BlockNCT03757377BackBeat Medical Inc203
已完成
不适用
A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 PatientsCOVID-19NCT04347174Cadila Pharnmaceuticals40
已完成
不适用
A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in ChildrenElevated Blood Lead LevelsNCT04891666Novozymes A/S66
已完成
3 期
Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to RituximabArthritis, RheumatoidNCT02792699Amgen311