跳至主要内容
临床试验/CTRI/2017/06/008870
CTRI/2017/06/008870已完成不适用

A single arm, prospective study to determine safety and efficacy of Syrup Urophyll, 10 ml three times a day in patients diagnosed with chronic kidney disease and not on dialysis.

Thinq Pharma CRO Limited1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2016年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Serum Creatinine

研究概览

简要总结

The Investigational Product (IP) which is Syrup Urophyll is an approved and marketed adjuvant and an anti-oxidant product. It has sodium-copper-chlorophyllin as the main ingredient along with sorbitol, glycerin etc. It is approved and marketed as a food ingredient having fssai license number: 11513029000653. The proposed study is to see the safety and efficacy of the IP in patients with compromised kidney functions. All the patients enrolled in the study will get the IP. No medicine which his/her physician is giving/intends to give will be stopped. Thus, patients enrolled in the study will get the IP in addition to the standard of care, otherwise the patient would have received. Known and old patients of CKD, who are already on medications, will also be enrolled if they are eligible and willing. Their regular medicines will not be stopped or altered due to their participation in the study. They also will be getting IP in addition to their routine standard of care. Though study period for enrolled patients is 3 months, IP will be given for 2 months only. Thus patients will be off the IP for last 30 days, though the standard of care or regular medicines will be continued throughout. The IP may help reduce serum creatinine, increase the glomerular filtration rate (GFR) and thus benefit patients manage their CKD in a better manner. As participants will be given the standard of care which otherwise might have been given to them. Hence they are not deprived ethically of their right of standard of care.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Known case of chronic kidney disease aged between 18 and 70 years 2.Written informed consent 3.Serum Creatinine is at least 1.8 mg/dL at the time of screening 4.Blood pressure and blood sugar that is well controlled in the last one year.

排除标准

  • 1.Patients who has had episode(s) of dialysis in last 6 months 2.History of kidney transplant 3.Pregnant or breast-feeding woman 4.Nephrotic syndrome 5.Patients with uncontrolled diabetes, hypertension, gout or other illness 6.Participant of other clinical trial.

结局指标

主要结局

Serum Creatinine

时间窗: 2 and 3 months post enrollment

次要结局

  • Sr. Urea, Hemoglobin, Quality of Life(2 and 3 months post enrollment)

研究者

申办方类型
Pharmaceutical industry-Global

研究点 (1)

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