A clinical trial to evaluate the efficacy and safety of Glutathione in patients with alcoholic and non-alcoholic fatty liver disease.

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000087

Enrollment

100

Registered

2010-02-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K700- Alcoholic fatty liver

Interventions

Intervention1: Glutathione: 600mg Injection upto 4 weeks Intervention2: Glutathione: a total of 1800mg diluted in 5% dextrose solution in divided dosage in case of IV injection for at least 2 weeks. C

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: ? 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

Design outcomes

Primary

Measure	Time frame
Liver Function parametersTimepoint: 2-4 weeks	—

Secondary

Measure	Time frame
Ultrasonography of liverTimepoint: up to 4 weeks	—

Countries

India

Contacts

Public ContactDr Milan Satia

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026