Observational Post Marketing Surveillance Study To Substantiate the Safety And Efficacy of Renadyl in the Patients of Stage III And IV of Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 2. Reduction in Blood Urea Nitrogen (BUN) Level
研究概览
简要总结
Renadyl [each capsule contains 45 Billion CFU of Streptococcus thermophilus (KB19), Lactobacillus acidophilus (KB27) and Bifidobacterium longum (KB31)] is a FSSAI approved nutraceutical product used as a supportive therapy for stage III and stage IV chronic kidney disease patients.
In Patients of chronic kidney disease the kidney function declines, nitrogenous wastes builds up in the blood and diffuses into the intestinal fluid by natural physiological process in colon via an extensive network of blood vessels. Probiotic microbes present in Renadyl enter the large intestine through ileo-caecal junction. Once they reach in the colon, the microbes target and metabolize the uremic nitrogenous wastes as nutrients for its growth, the microbes begin to multiply, and this in turn allows for even greater diffusion of nitrogenous wastes from the circulating blood stream into the bowel.
Several clinical trials of Renadyl in patients suffering from CKD of stage III and stage IV found that Renadyl is efficacious for reduction in BUN, Serum creatinine, C-reactive protein, Uric acid, Total Indoxyl glucoronide with increase in eGFR and the quality of life. It was also found to be with acceptable safety profile. Taking into account, the superiority in efficacy and safety along with patient compliance, we are proposing this phase IV clinical trial of Renadyl in India. The main rationale behind this clinical trial is to test the efficacy and safety of Renadyl in Indian patients and document the same thing.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
入选标准
- •1.]Ages: 18-75 years 2.]Gender eligible for Study: both Males and Females 3.]Patients of stage III and IV chronic kidney disease (GFR from 15-59mL/min per 1.73 m2) 4.]Willing to sign on the informed consent form 5.]Patients who can adhere to the Protocol.
排除标准
- •1.]Patients known to be hypersensitive to the study product 2.]Patients on dialysis or have undergone dialysis in the past 3.]Pregnant or Lactating Women 4.]HIV/AIDs and Liver disease patients 5.]Antibiotic treatment at the time of screening or within 30 days before screening 6.]Immunosuppressive treatment at the time of screening or within 90 days before screening 7.]Patients suffering from Irritable Bowel Syndrome, Inflammatory Bowel Disease and patients who have undergone resection surgeries of the GI tract 8.]Patients with CKD due to obstructive uropathy and ADPKD 9.]Patients having severe cardiac arrhythmias and grade III & IV (NYHA classification) of CHF 10.]Patients with active dependency on drugs/alcohol for the last 12 months 11.]Patients having history of taking any probiotic for 3 months at the time of screening 12.]Patients who cannot adhere to the Protocol (Mentally Ill and Patients with Psychological problem).
结局指标
主要结局
2. Reduction in Blood Urea Nitrogen (BUN) Level
时间窗: At day 1, day 90 and day 180
3. Reduction in Serum Urea Level
时间窗: At day 1, day 90 and day 180
4. Reduction in Serum Uric Acid Level
时间窗: At day 1, day 90 and day 180
1. Reduction in Serum Creatinine Level
时间窗: At day 1, day 90 and day 180
次要结局
- 1.Elevation in Creatinine Clearance(2. Elevation in estimated Glomerular Filtration Rate (eGFR))
研究者
Dr Mayuresh Kiran
Centaur Pharmaceuticals Pvt Ltd