To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis
\- Methotrexate was indeed a common and effective treatment for rheumatoid arthritis, psoriatic arthritis and psoriasis. Methotrexate-related hepatotoxicity are common occur 1:1,100 persons. Liver abnormalities varies from asymptomatic liver enzyme elevation to fatal hepatic necrosis and liver fibrosis. Methotrexate was discontinued owing to liver dysfunction in 7.4%
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Bangkok, Thailand, 10400, Bangkok, Thailand
RECRUITINGAST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L)
elevation of AST or ALT more than 1X ULN (% participant)
Time frame: 12 weeks
AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN
elevation of AST or ALT more than 2X ULN (% participant)
Time frame: 12 weeks
AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L)
elevation of AST or ALT more than 3X ULN (% participant)
Time frame: 12 weeks
AST or ALT > 5X ULN or >3X ULN ( normal AST and ALT 0-50 U/L) with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin > 2X with jaundice
elevation of AST or ALT \> 5X ULN or \>3X ULN with symptom of hepatitis such as Fatique, abdominal pain, nausea, vomiting or total bilirubin \> 2X with jaundice (% participant)
Time frame: 12 weeks
Discontinuation rate of methotrexate
Rate of methotrexate discontinuation (%)
Time frame: 12 weeks
Adverse events
Rate of any adverse events (%)
Time frame: 12 weeks
Change of DAS-28 ESR or CRP Score
Change of DAS-28 ESR or CRP Score for patients with Rheumatoid arthritis and psoriatric arthritis (unit)
Time frame: 12 weeks
Change of BASDAI Score
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Change of BASDAI Score for AS (unit)
Time frame: 12 weeks
Change of ASDAS ESR or CRP Score
Change of ASDAS ESR or CRP Score for AS (unit)
Time frame: 12 weeks
Change of BSA for psoriasis
Change of BSA for psoriasis (unit)
Time frame: 12 weeks