Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02019056
Eligibility Criteria:
Inclusion Criteria:
* •Patients over 18, under 70 years of age
* The chronic alcohol intake patients
* Current the heavy drinker over 3month, Day the average alcohol consumption Male\>=60g, Female\>=40mg y-GTP increase Male\>=75, Female\>=35
* Over 1.5 ratio of AST to ALT
* Patients who have chronoc alcohol disease
Exclusion Criteria:
* Patients who have liver disease with the cause different with the alcohol except
* Patients who have pyridoxine allergy or history
* Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
* Patients taking other investigational product within 90 days prior to the participation in the study.
* Patients who has been taken any medications that could affect the treatment : hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, lont-term use of NSAIDs, statins, neuroleptics, anti convulsive medications, high-dose acetaminophen(\>=2.5g/day)
* Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
* Patient who considered ineligible for participation in the study as Investigator's judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02019056
Study Brief:
Protocol Section:
NCT02019056