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临床试验/CTRI/2023/12/060567
CTRI/2023/12/060567尚未招募不适用

A Retrospective Study to Evaluate the Effectiveness of NefroSave® Supplementation on Change in Microalbuminuria in Diabetes Mellitus or Hypertension: A Real-World Retrospective Study from Electronic Medical Records

Fourrts India Laboratories Pvt Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年12月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
1
主要终点
Change in urinary albumin to creatinine ratio (uACR) from baseline to study end

研究概览

简要总结

This study is based on data gathered in the electronic medical records for patients of diabetic and hypertensive patients diagnosed with stage 1, stage 2, or stage 3 chronic kidney disease (CKD) and prescribed to receive NefroSave® supplementation. The information will be extrapolated from the electronic medical record database in an anonymized aggregate manner so as to mask patient identifiers. Each patient gets a unique patient identifier or a unique patient ID once they are registered on the database and patient

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patients with diabetes mellitus or hypertension maybe diagnosed with chronic kidney disease (CKD) Stage 1, Stage 2 and up to Stage
  • Adult patients with microalbuminuria result ranging from 30-300mg/day.

排除标准

  • Patients with incomplete medical records with respect to the required study parameters.

结局指标

主要结局

Change in urinary albumin to creatinine ratio (uACR) from baseline to study end

时间窗: 3 months

次要结局

  • 1. Change in microalbuminuria within treatment time period of 3 months

研究者

申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Monjori Mitra

Medclin Research Pvt Ltd

研究点 (1)

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