NCT06277635招募中不适用
Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases, a Double-blind Randomized Controlled Trial
Phramongkutklao College of Medicine and Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L)
研究概览
简要总结
To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis
详细描述
- 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%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 20 years
- •Diagnosis at least one of the following
- •Rheumatoid arthritis according to American College of Rheumatology/ The European Alliance of Associations for Rheumatology 2010(ACR/EULAR2010) with at least one joint swelling or tenderness or
- •Psoriatric arthritis according to CASPAR classification criteria with at least one joint swelling or tenderness, or at least one site dactylitis or enthesitis or Psoriasis by dermatologist with active skin lesion
- •No previous treatment with methotrexate or treatment with methotrexate within 30 day before randomization
- •No previous treatment with other conventional synthetic DMARDs other than methotrexate such as sulfasalazine, hydroxycholoquine, leflunomide
- •No previous treatment with biologic DMARDs such as anti-TNF
- •Can follow the treatment protocal
排除标准
- •Pregnancy or planning for pregnancy
- •Breastfeeding women
- •Ongoing treatment with active malignancy
- •GFR < 30 ml/min/1.73m2
- •Previous documented of HIV infection
- •Chronic alcohol drinking ≥ 3 times/wk or drug abuse within 6 months prior to randomization
- •Positive of HbsAg, anti HCV
- •Previous documented of preexisting liver disease such as alcoholic liver disease, liver cirrhosis, autoimmune hepatitis
- •AST or ALT > ULN ( 0-50 U/L )
- •WBC < 3,000/ul or platelet < 100,000 /ul, ANC < 1,500/ul
- •ILD diagnosed by rheumatologist and pulmonologist from chest X ray and HRCT
- •History documented silymarin hypersensitivity or severe adverse effects diagnosed by physician or pharmacist from PMK hospital or from history drug allergy or symptoms such as rash, chest tightness, dyspnea, diarrhea and hypotension
- •Cannot follow up on treatment protocal
研究组 & 干预措施
Silymarin group
Active Comparator
Silymarin 140 mg oral tid pc + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks
干预措施: Silymarin (Drug)
Placebo group
Placebo Comparator
Placebo + methotrexate weekly + folic acid 5 mg oral OD pc for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
AST or ALT > 1X ULN ( normal AST and ALT 0-50 U/L)
时间窗: 12 weeks
elevation of AST or ALT more than 1X ULN (% participant)
次要结局
- AST or ALT > 2X ULN ( normal AST and ALT 0-50 U/L) AST or ALT > 2X ULN AST or ALT > 2X ULN(12 weeks)
- AST or ALT > 3X ULN ( normal AST and ALT 0-50 U/L)(12 weeks)
- Change of BSA for psoriasis(12 weeks)
- Change of ASDAS ESR or CRP Score(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(12 weeks)
- Discontinuation rate of methotrexate(12 weeks)
- Adverse events(12 weeks)
- Change of DAS-28 ESR or CRP Score(12 weeks)
- Change of BASDAI Score(12 weeks)
研究者
研究点 (1)
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