A clinical trial to evaluate the efficacy and safety of Glutathione in patients with alcoholic and non-alcoholic fatty liver disease.
Phase 3
Completed
- Conditions
- Alcoholic fatty liver,
- Registration Number
- CTRI/2010/091/000087
- Lead Sponsor
- Lyka Labs Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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) 4.
- Patients with non-alcoholic fatty liver as confirmed by liver sonography.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Liver Function parameters 2-4 weeks
- Secondary Outcome Measures
Name Time Method Ultrasonography of liver up to 4 weeks
Trial Locations
- Locations (5)
Aashirwad Hospital
🇮🇳Thane, MAHARASHTRA, India
Sai Seva Hospital & Research Center
🇮🇳Nashik, MAHARASHTRA, India
Shah heart & Medical hospital
🇮🇳Kirti, India
Shreeji Hospital
🇮🇳Nashik, MAHARASHTRA, India
Shukla's Hospital
🇮🇳M.G.Road,,Dist., Surat, India
Aashirwad Hospital🇮🇳Thane, MAHARASHTRA, IndiaDr SV DeshpandePrincipal investigator0222587006svshrikant@gmail.com