CTRI/2012/03/002516已完成4 期
An open label randomized clinical study to evaluate the impact of Proseventy efficacy and safety in dialysis patients. - IMPROVES STUDY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1 Patient willing to sign informed consent form.
- •2 Age of patient is 18 years or above.
- •3 Patients in the middle to high socioeconomic group.
- •4 Serum albumin < 3.8g/100ml
- •5 Patients on maintenance dialysis for atleast for 3 months.
- •6 Adequate dialyzed as per investigator
- •7 Absence of uremic symptoms
- •8 Patients classified as malnourished as per criteria listed in Annexure 1 (Diagnostic criteria for PEW as ISRNM)
排除标准
- •1 Patients who do not have clinical PEW as per Annexure 1
- •2 Patients with systemic infection like TB or Malaria.
- •3 Patients who are currently using/ have discontinued use of any nutritional supplement
- •4 Plan for kidney transplantation within study period
- •5 Females who are pregnant or breast feeding
- •6 Life expectancy less than 6 month
- •7 Patient changed from haemodialysis to peritoneal dialysis
研究者
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