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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017070
Enrollment
80
Registered
2019-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention1: Enzobiotics: 550 mg capsule Oral Route 1 capsule to be taken 3 times daily 5 minutes before food for 3 months Control Intervention1: Placebo: Maltodextrin 550mg Oral route 1 capsule to

Sponsors

Myline Biotech India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1 Assess the Safety and Efficacy of Enzobiotics in CKD Stage 3 4 and Stage 5 Patients 2 Improvement in eGFR calculated by CKD EPI formula 3 Change in P Cresols and Indoxylsulfhate Protein bound Uremic toxins levels & Quality of life SF 36 regular for CKD patients and SGA scoring Timepoint: 0 45 and 90 days—

Secondary

MeasureTime frame
Change in BUN Creatinine Hemoglobin Phosphorous Potassium Sodium Albumin serum Hs Crp Urea Total Protein Tryglycerides Total cholesterol HDL LDLTimepoint: 0 45 and 90 days—

Countries

India

Contacts

Public ContactP Prabhakaran

Mylin Biotech India Pvt Ltd

p.prabhakaran@mylinbiotech.com9008641199

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026