| Trial ID: | L0961 |
| Source ID: | CTRI/2010/091/000087
|
| Associated Drug: |
Glutathione
|
| Title: |
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.
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Health Condition 1: K700- Alcoholic fatty liver
|
| Interventions: |
Intervention1: Glutathione: 600mg Injection upto 4 weeks<br>Intervention2: Glutathione: a total of 1800mg diluted in 5% dextrose solution in divided dosage in case of IV injection for at least 2 weeks.<br>Control Intervention1: NIL: NIL<br>
|
| Outcome Measures: |
Liver Function parametersTimepoint: 2-4 weeksUltrasonography of liverTimepoint: up to 4 weeks
|
| Sponsor/Collaborators: |
Lyka Labs Limited
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 3
|
| Enrollment: |
100
|
| Study Type: |
Interventional
|
| Study Designs: |
Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label
|
| Start Date: |
04/02/2010
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 November 2021
|
| Locations: |
India
|
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1302
|
