A Phase III, multicenter, open label, single treatment clinical study to evaluate the safety and efficacy of Glutathione 600mg Injection in patients with alcoholic and non-alcoholic fatty liver disease.

yka Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1. Written informed consent from the patient.
•2. Age above 18 years inclusive.
•3. Diagnosis of Alcoholic liver disease (Changes in the liver as inflammation and lead to fatty liver as confirmed by Ultrasonography of liver and also based on 3-4 fold higher levels of SGOT and SGPT) clinically verified by a physician based on WHO criteria for alcohol abuse, dependence, and harmful use (tolerance, history of withdrawal syndrome, excessive use, unsuccessful control, use resulting in physical or psychological harm)
•4. Patients with non-alcoholic fatty liver as confirmed by liver sonography

•? Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
•? HIV positive individual.
•? Hepatitis B & Hepatitis C positive individual
•? Specific non-alcoholic liver disease
•? Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
•? Patients will be excluded who present with other chronic diseases that may affect liver function, such as cancer, congestive heart failure, renal insufficiency with serum creatinine greater than 1.4 mg/dl following rehydration, or infectious illness.
•? Known hypersensitivity to Glutathione.
•? Patient with any other gastrointestinal disorder.
•? Patient who is consuming/ has received drugs, which have interaction with Glutathione, during last 14 days.
•? Participation in any other clinical trial during last 30 days

发起方

yka Labs Limited