CTRI/2010/091/000087已完成3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Liver Function parameters
研究概览
简要总结
This study is an open label, single treatment multicenter clinical trial evaluating safety and efficacy of Glutathione 600mg Injection in patients with alcoholic and non-alcoholic fatty liver disease that will be conducted at four centers in India. The primary outcome measures will be lowering of Liver function tests and improvement in liver ultrasonography during 4 weeks treatment. The secondory outcome will be evaluating safety aspects of the treatment.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent from the patient.
- •Age above 18 years inclusive.
- •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)
- •Patients with non-alcoholic fatty liver as confirmed by liver sonography.
排除标准
- •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.
结局指标
主要结局
Liver Function parameters
时间窗: 2-4 weeks
次要结局
- Ultrasonography of liver(up to 4 weeks)
研究者
研究点 (5)
Loading locations...
相似试验
招募中
3 期
Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid TumorsLocally Advanced Solid TumorNCT06658353Jiangsu vcare pharmaceutical technology co., LTD54
Unknown
3 期
A Study of Amphotericin B Liposome for Injection in Patients With Persistent Neutropenia and FeverNeutropenia and FeverNCT05108545CSPC ZhongQi Pharmaceutical Technology Co., Ltd.93
进行中（未招募）
3 期
Study of CM310 in Adolescent Subjects With Atopic DermatisAtopic DermatitisNCT06495229Keymed Biosciences Co.Ltd180
已完成
3 期
A Phase 3b, Open-label, Multi-center Study on Durvalumab in Combination With Gemcitabine-based Chemotherapy as 1L Treatment for the Chinese Patients With Unresectable Biliary Tract Cancers (BTC)Biliary Tract CancersNCT05924880AstraZeneca116
已完成
3 期
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B PatientsHemophilia BNCT03569891CSL Behring67