CTRI/2020/01/023033进行中(未招募)1 期
Evaluation of efficacy and safety of NRL/2019/NL in Liver Disorder Patients with Abnormal Liver Function Test (LFT) A randomized, parallel arm, interventional, prospective clinical study. - NI
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试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Males or females 18-65 years of age
- •Diagnosis of hepatic disorder with abnormal LFT with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain
- •Subjects with or without fatty liver changes observed in Ultrasonography of abdomen will be enrolled in the study
- •Serum total bilirubin level less than or equal to 2 mg/dl, or AST or ALT 2 times than normal values
- •Subjects willing to sign inform consent form
排除标准
- •Evidence of chronic viral hepatitis (Hepatitis B or C) and Biliary obstruction
- •Previous entry into the study, or use of either prednisolone or PTX within 6 weeks of admission
- •AST >500 U/L or ALT >300 U/L
- •Suspected hypersensitivity to contents of study drug
- •Advanced liver disease, subjects with serious illness
- •History of gastritis, peptic ulcer, bleeding ulcer
- •Patients with a renal failure
- •Pregnant or lactating women
- •Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment
研究者
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