A prospective, single center, randomized, open label, two arm clinical study to evaluate the effects of Alpha Keto Analogues of essential amino acids with standard of care versus standard of care alone in patients with hepatic encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in arterial ammonia concentration from baseline
研究概览
简要总结
This is a randomized, controlled, prospective clinical study with a total participation duration of up to 94 days for each subject, starting from the day of enrolment. The study will begin with a screening visit (Visit 1) conducted between Day -3 and Day -1 to assess eligibility. Eligible subjects will undergo randomization at the baseline visit (Visit 2) on Day 0. The treatment period will span approximately three months, during which participants will attend follow-up visits on Day 30 (±4 days), Day 60 (±4 days), and Day 90 (±4 days). The primary endpoints of the study include changes in arterial ammonia levels. Secondary endpoints include improvement in quality of life and mental state examination scores. Adverse events will be monitored throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18 to 65 years male and female both.
- •Cirrhosis diagnosed on the basis of clinical features, biochemical, radiological and or liver histology data.
- •Diagnosed with hepatic encephalopathy having Grade 2 and 3
- •Diagnosed with hepatic encephalopathy at least 7 days prior to screening.
- •Ammonia level more than 170.
排除标准
- •Current or recent (less than 6 weeks) use of alcohol
- •Use of antibiotics within last 6 weeks
- •Use of lactulose, lactitol, L-ornithine L-aspartate and zinc within the last 6 weeks
- •Use of interferon or psychoactive drugs like benzodiazepines, psychotropic drugs, anti-epileptics within the last 6 weeks
- •Infection or gastrointestinal hemorrhage within the last 6 weeks
- •Advanced medical problems like congestive cardiac failure, advanced pulmonary disease or renal insufficiency or electrolyte imbalance
- •Hepatocellular carcinoma
- •History of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
- •Pregnancy and breastfeeding
- •Neurological or psychiatric problems which may influence quality of life measurement.
- •Poor vision or motor defects which interfere with the performance of psychometric tests.
- •Any condition which may not appropriate for study result as per PI discretion.
结局指标
主要结局
Change in arterial ammonia concentration from baseline
时间窗: Screening, day 30, day 60, day 90
次要结局
- Change in grades of hepatic encephalopathy(Screening, Day 90)
- Reduction of ammonia level to at least 50% from the baseline at the end of treatment.(Baseline, Day 90)
- Improvement in quality of life using EQ-5D(Baseline, Day 90)
- Mental State Examination using MMSE(Baseline, Day 90)
- Adverse Events(Screening, Day 0, day 30, day 60, day 90)
研究者
Dr Vinay Kumar
GSVM Medical Collage