A prospective ,Open Label,Observational Study to evaluate the Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- •Quality of life with improvement in nutritional status
研究概览
简要总结
Detailed Description :
Chronic kidney disease (CKD) is a global health issue that has a substantial impact on affected
Individuals. The prognosis of dialysis patients is poor with 30 to 50 percent 5 year survival in
nondiabetic patients and 25 percent in diabetic patients. Cardiovascular diseaseaccounts for
approximately half of death of dialysis partients. Chonic inflammation, which is widely seen in long-
term dialysis patients, is associated with malnutrition, atherosclerosis and an increased mortality risk.
Inflammatory markers such as C-reactive protein (CRP), IL-6, Il-18 and TNF-alpha, are elevated in
dialysis and can predict cardiovascular envent and all-cause mortality.
Synbiotics ( combination of Probiotics and Prebiotics) are microorganisms given along with
Oligosaccharides that have beneficial properties for the host. Three described benefits includes
suppression of growth or epithelial binding/invasion by pathogenic bacteria, improvement of
intestinal barrier function and modulation the immune systems.
Several probiotics preparations induce protective cytokines, including IL-10, and suppresses
proinflammmatory cytokines, such as TNF-alpha and IL-6. Intestinal microflora is deranged in
hemodialysis (HD) patients and Predialysis Patients as an increase in aerobic bacteria such as E.coli
and a decrease in anaerobic bacteria such as Bifidobacterium. One study reported that oral
administration of Bifidobacterium longumm in gastroresistant capsules decreases the the pre-HD
serum levels of homocysteine and indoxylsulfhate. Another small-scale study from Japan showed that
synbiotics containing lactobacilli and can reduce serum level of p-Cresol in HD patients. High –serum
p-cresyl sulfate and indoxyl sulfate levels were associated with overall mortality and cardiovascular
disease in HD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient aged ≥18 to 65 years of both female and male to be included 2.CKD patients with GFR <30 ml/minute 3.HD patients GFR<15ml/minute 4.Stage 3 and Stage 4 & 5 CKD patients 5.Patients who are on Dialysis for at least 3 months from the day of screening and Patients who are not doing well on Dialysis 6.Patient with the ability to provide written informed consent form 7.Patients willing to comply with the protocol requirements.
排除标准
- •1.Patients with known hypersensitivity to any of the components of the formulation 2.Patient with history of treatment with NitroPhage Forte 3.Active infectious conditions within the last 30days.
- •4.New York Heart Association (NYHA) Classification Category III and IV Cardiac Insufficiency, Ischaemic Heart Disease, Coronary Insufficiency or any other clinically significant cardiovascular disease.
- •5.Patients who have participated in any clinical trial in the past 1 month.
- •6.Autoimmune disease e.g. SLE/Vasculities 7.Diabetic foot infection patients 8.Pregnant or lactating women.
- •9.Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
结局指标
主要结局
•Quality of life with improvement in nutritional status
时间窗: 6 weeks
•Improvement in Anti inflammatory markers such as TNF α and IL6
时间窗: 6 weeks
次要结局
- •Improvement in Lab Values such as BUN,Creatinine.(• Improvement in Uraemic Pruritus)