Health Condition 1: - Health Condition 2: Z728- Other problems related to lifestyle
Conditions
Interventions
Intervention1: Enzobiotics: Enzobiotics (Pre and Probiotics with Enzyme)Phase 3 completed and published. Day0 shall be compared with Day180. Duration shall be 6 months and Dosage shall be 1 capsule B
Sponsors
Mylin Biotech India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 18- 70yrs 2. Stage 1 to Stage 5 with CKD. 3. Patient wanting to delay dialysis 4. Willing to come for regular follow -up visits 5. Able to give written informed consent
Exclusion criteria
Exclusion criteria: 5. Subjects with uncontrolled cardiovascular events. 6. Patients on other Pre- Probiotic therapy and with enzymes 7. Patients with acute coronary syndrome. 8. Patients who have been prescribed Synbiotics and Enzymes 9. Subjects with any other severe systemic illness and in the opinion of the investigator would be non-compliant with the visit schedule or study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assess the Safety and Efficacy of Enzobiotics in CKD Stage 1 - Stage 5 Patients. 2. Change in P-Cresols and Indoxylsulfhate Protein bound Uremic toxins levels based on EETOX study equation & Quality of life SF-36 (regular for CKD patients) 3. EETOX 2 shall group the patients ie., CKD with Hypertension, CKD with Diabetes , CKD a combination of Diabetes and Hypertension and CKD (4 groups) evaluate and compare the efficacy in each group. Timepoint: End points shall be measured between Day0 to Day 180. 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BUN, Creatinine, Hemoglobin, Phosphorous, Potassium, Sodium , eGFR (Cockgrauft or MDRD )Albumin serum, Urea , Total Protein, Triglycerides Total cholesterol, HDL, LDL, RBC & PlateletsTimepoint: 180 Days | — |
Countries
India
Contacts
Public ContactDr Sanjay Sreenivasa
Center for Kidney and Diabetes
Outcome results
None listed