Evaluation of Safety and Efficacy of fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets as supportive and maintenance therapy in hepatitis: A Phase IV, Prospective, Open Label, Multi-centric, Single Arm, Clinical Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 7
- 主要终点
- 1.Incidence, intensity, and causal relationship to labelled and un-labelled adverse reaction during the study period (Post screening after drug administration)
研究概览
简要总结
It is a Phase IV, Prospective, Open Label, Multi-centric, Single Arm, Clinical Study.
To evaluate the Efficacy & safety of fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets as supportive and maintenance therapy in Hepatitis.
200+20 subjects will be enrolled in the study to evaluate 200 enrolled subjects who completes the study
The fixed dose combination of L-Ornithine-L-Aspartate 150mg, Pancreatin IP 100mg enteric coated tablets possess hepatoprotector-detoxicant, hypoazotemic action which is based on direct influence upon the basic mechanism of ammonia neutralization in hepatocytes (formation of urea from ammonia, increase in glutamine synthesis).
In furtherance to continuous assessment of benefit risk profile of the FDC L-Ornithine-L-Aspartate 150mg, Pancreatin IP 100mg enteric coated tablets, the present phase IV study has been planned to assess the safety and efficacy profile in Asian Indian population suffering with hepatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/Female patients aged between 18-70 years with a clinical diagnosis of Hepatitis.
- •The definition of Hepatitis is as mentioned below: Hepatitis is a term to describe inflammation (Swelling) in the liver.
- •It can be caused due to viral infection or when liver is exposed to harmful substances such as alcohol.
- •Hepatitis may occur with limited or no symptoms, but often leads to jaundice, anorexia (poor appetite) and malaise.
- •Hepatitis is of two types: Acute and Chronic.
- •2.Willingness to comply with the study schedule and procedures.
- •3.Patient willing to give written informed consent prior to screening.
排除标准
- •1.Subject not willing to give written informed consent 2.Severe renal insufficiency (A serum creatinine value over 1.5 mg/100 ml) 3.Known hypersensitivity to any ingredient of the study drug.
- •4.Acute or chronic liver failure 5.Severe sepsis 6.Advanced cardiac or pulmonary disease 7.Neurologic disease (including head injury and drug intoxication).
- •8.Pregnancy and Lactation.
- •9.Female Subject not ready to use contraceptive measures during the trial period 10.Subject with any condition which in opinion of the investigator makes the him/her unsuitable for inclusion.
结局指标
主要结局
1.Incidence, intensity, and causal relationship to labelled and un-labelled adverse reaction during the study period (Post screening after drug administration)
时间窗: Day 0 to Day 14
2.Incidence, intensity, and causal relationship to Serious Adverse Events (SAEs) during the entire study period (Post screening after drug administration)
时间窗: Day 0 to Day 14
次要结局
- Improvement in laboratory parameters SGOT, SGPT, Alkaline Phosphatase, Serum Ammonia, Serum Bilirubin at the day 0, day 7 and day 14 of the treatment.(Physicians assessment in improvement according to a modified version of the Clinical Global Impression-Improvement (CGI-I) scale.)