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EETOX-K

A prospective open label randomized trial evaluating the safety and efficacy of Enzobiotics and alpha Ketoanalogue in CKD patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110580
Enrollment
150
Registered
2026-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Enzobiotics: First group of Subjects will be instructed to take the Enzobiotics twice daily 5 minutes before major food through oral route of administration Intervention2: Enzobiotics:

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects aged between 18 - 80yrs 2.eGFR greater than 15 ml per min per 1.73 m2 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: 1.Pregnant and lactation. 2.Autoimmune disease e.g. SLE/Vasculitis. 3.Subjects with hepatic impairment (SGOT or SGPT levels greater than 3 times the upper limit) 4.Active infection patients. 5.Subjects with uncontrolled cardiovascular events or acute coronary syndrome. 6.Patients who have been prescribed Synbiotics and Enzymes. 7.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

MeasureTime frame
1.Assess safety and efficacy of Enzobiotics and alpha ketoanalogue in CKD patients 2. Retardation of CKD progression 3. slope of eGFR and uACR Timepoint: 180 days Trial, 365 days follow up

Secondary

MeasureTime frame
Change in BUN, Creatinine, Haemoglobin, Phosphorous, Calcium, Potassium, Sodium, Serum Albumin, Urea, Total Protein, Triglycerides, Total cholesterol, HDL, LDL, Hospitalization during study period, CBC and in vitals Heart rate, Change in Proteinuria, UACR, Patient Reported outcome SF36Timepoint: Day 1, Day 90, Day 180

Countries

India

Contacts

Public ContactDr Nisith Kumar Mohanty

Apollo Hospitals

nkmty2002@gmail.com9337103451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026