Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease and Alcoholic Hepatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | enteric coated capsule |
|
| MG 500mg | Experimental | Metadoxine + garlic oil |
|
| MG 1000mg | Experimental | Metadoxine + garlic oil |
|
| Metadoxine 500mg | Sham Comparator | enteric coated capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo /bid P.O | Drug |
| ||
| MG-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in AST at 14weeks | To evaluate the liver function to assess improvement of the MG on change in AST lab value assessed from baseline to 12 weeks in patients with Alcoholic fatty liver disease | 14Weeks |
| Number of Participants with Adverse Events (Safety) | Adverse Event: Physical examine, Lab test, Vital sign, ECG, symptom, start day and time, end day and time, severity, progress, outcome, relation with investigational product. | 14weeks |
| To evaluate ALT normalization | To evaluate ALT normalization assessed by comparing the percentage. | 14weeks |
| To evaluate AST normalization | To evaluate AST normalization assessed by comparing the percentage. | 14weeks |
| change in AST, ALT, total lab billirubin lab value | To evaluate the efficacy of the MG on change in AST, ALT, total lab billirubin lab value assessed from baseline to 4, 8, 12 weeks in patients with Alcoholic fatty liver disease | 14weeks |
Not provided
Not provided
Inclusion Criteria:
•Patients over 18, under 70 years of age
The chronic alcohol intake patients
Over 1.5 ratio of AST to ALT
Patients who have chronoc alcohol disease
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang university Hospital | Guri-si | Gyeonggi-do | 471-701 | South Korea |
Not provided
| ID | Term |
|---|---|
| D005235 | Fatty Liver, Alcoholic |
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
Not provided
Not provided
| ID | Term |
|---|---|
| C037845 | metadoxine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| MG-2 : MG1000mg, Placebo /bid P.O | Drug |
|
| metadoxine | Drug |
|
|
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D006505 | Hepatitis |