NCT02248792Unknown4 期
Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in health related quality of life
研究概览
简要总结
Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA >10% or PASI >12) -
排除标准
- •Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past
研究组 & 干预措施
Group A
Experimental
Methotrexate 10mg orally once weekly
干预措施: Methotrexate (Drug)
Group B
Active Comparator
Methotrexate 25mg orally once weekly
干预措施: Methotrexate (Drug)
结局指标
主要结局
Improvement in health related quality of life
时间窗: 12 weeks
次要结局
- comparison of improvement in health related quality of life between Group A and Group B(12 weeks)
研究者
C V Krishna
C V Krishna
Narayana Medical College & Hospital
研究点 (1)
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