A prospective randomized control study to assess the efficacy of methotrexate monotherapy versus methotrexate with metformin in chronic plaque psoriasis with metabolic syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- For Psoriasis assesed by PASI score . Improvement in skin lesions will be noted using serial photographs taken . For Metabolic Syndrome assessed by parameters like FBS ,PPBS ,BP ,Waist circumference and Fasting lipid profile
研究概览
简要总结
A prospective randomized control trial to assess the efficacy of methotrexate monotherapy versus methotrexate with metformin in chronic plaque psoriasis with metabolic syndrome
patients of chronic plaque psoriasis with metabolic syndrome of both sex aged 18-65 years who are willing to take part in the study and willing to take photographs of skin lesions are split into two groups after conducting thorough systemic and dermatological examination one group is treated with oral methotrexate 15 mg/week for 16 weeks with regular assessment every 4 weeks and another group is treated with oral methotrexate 15mg/week with oral metformin 1g daily in divided doses for 16 weeks with regular assessment every 4 weeks .both groups will be followed up after the study period every 4 weeks for a period of 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •moderate to severe chronic plaque psoriasis with PASI more than or equal to 5 with metabolic syndrome, patients of either sex aged 18-65 years, patients who are willing to participate in the study, patients who are willing to take photographs of skin lesions.
排除标准
- •severe types such as erythrodermic , guttate , pustular psoriasis and psoriatic arthritis , liver disease , cardiac disease with history of CCF , renal failure , pregnancy and lactation , patients with active and latent infections.
- •tuberculosis , HIV ,syphilis , hepatitis , known contraindication to methotrexate and metformin.
结局指标
主要结局
For Psoriasis assesed by PASI score . Improvement in skin lesions will be noted using serial photographs taken . For Metabolic Syndrome assessed by parameters like FBS ,PPBS ,BP ,Waist circumference and Fasting lipid profile
时间窗: Every 4 weeks till the end of study which is 16 weeks and during follow up period of 12 weeks
次要结局
- Subjective satisfaction will be assessed by Dermatology Life Quality Index questionnaire at the end of study(After 16 weeks at the end of the study)
研究者
Dr Deepa K
Government stanley medical college and hospital , chennai