A prospective, double blind,randomized, placebo controlled Interventional study to evaluate the safety and efficacy of Enzobiotics ( Synbiotics and Proteolytic Enzymes )in pre dialysis kidney disease patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- 1 Assess the Safety and Efficacy of Enzobiotics in CKD Stage 3 4 and Stage 5 Patients
研究概览
简要总结
This is a prospective, double blind, randomized, placebo controlled Interventional study to evaluate the safety and efficacy of Enzobiotics in pre dialysis kidney disease patients. The participating group is between the age of 18 to 70 years. A total of 80 patients will be recruited in the study both male and female. Patients with chronic kidney disease with stage 3,4 and 5 are included who are not undergoing dialysis.
All patients randomized either to active or placebo will have to take 3 capsules daily for 90 days.
Primary Study assessment is through the improvement in eGFR, P Cresols, Indoxysulfhate, Protein bound Uremic toxins levels, Quality of life SF-36 (regular for CKD patients) and SGA scoring from baseline to day 90.
Secondary study assessment is to understand Change in BUN, Creatinine, Hemoglobin, Phosphorous, Potassium, Sodium , Albumin serum, Hs Crp, Urea , Total Protein, Tryglycerides Total cholesterol, HDL, LDL, body weight, mid arm circumference, Waist : Hip ratio from baseline to day 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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 Subjects aged between 18 and 70yrs 2 Stage 3 4 and 5 3 Patients wanting to delay dialysis.
- •4 Willing to come for regular follow up visits 5 Able to give written informed consent.
排除标准
- •1 Pregnant and lactation.
- •2 Autoimmune disease e g SLE/Vasculities 3 Subjects with hepatic impairement (SGOT or SGPT levels more than 3 times the upper limit) 4 Diabetic foot infection patients 5 Subjects with uncontrolled cardiovascular events.
- •6 Patients who have been prescribed Synbiotics and Enzymes.
- •7Subjects with any other severe systemic illness and in the opinion of the investigator would be non compliant with the visit schedule or study procedures.
结局指标
主要结局
1 Assess the Safety and Efficacy of Enzobiotics in CKD Stage 3 4 and Stage 5 Patients
时间窗: 0 45 and 90 days
2 Improvement in eGFR calculated by CKD EPI formula
时间窗: 0 45 and 90 days
3 Change in P Cresols and Indoxylsulfhate Protein bound Uremic toxins levels & Quality of life SF 36 regular for CKD patients and SGA scoring
时间窗: 0 45 and 90 days
次要结局
- Change in BUN Creatinine Hemoglobin Phosphorous Potassium Sodium Albumin serum Hs Crp Urea Total Protein Tryglycerides Total cholesterol HDL LDL(0 45 and 90 days)