A Clinical study to understand the effect and safety of new treatment on patients with kidney problem

Completed

• Conditions: Chronic kidney disease, stage 3 (moderate),

• Registration Number: CTRI/2019/01/017070
• Lead Sponsor: Myline Biotech India Pvt Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-11
• Study Start: 2019-01-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Assess the Safety and Efficacy of Enzobiotics in CKD Stage 3 4 and Stage 5 Patients	0 45 and 90 days
2 Improvement in eGFR calculated by CKD EPI formula	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	0 45 and 90 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Bangalore Baptist Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Center For Kidney & Diabetes; 🇮🇳 Bangalore, KARNATAKA, India

K G Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Vision Multispeciality Hospital; 🇮🇳 Goa, GOA, India

Bangalore Baptist Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Chakko Korula Jacob

Principal investigator

9535236019

chakkokorulajacob@gmail.com