Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Nil: Nil
Control Intervention1: NIL: NIL
Sponsors
J. B. chemicals & pharmaceuticals LTD.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 years and above with a confirmed diagnosis of CKD Stage III and IV. 2.Patients with stable CKD management for at least two weeks prior to enrolling in the study. 3.Patients prescribed Lobun Forte alongside standard treatment for at least 12 weeks. 4.Patients willing to attend a follow-up visit at the end of 6 weeks and after 12 weeks.
Exclusion criteria
Exclusion criteria: 1.Patients undergoing haemodialysis. 2.Patients with acute kidney injury or a recent renal transplant. 3.Patients requiring hospitalization during the study period. 4.Pregnant or lactating women. 5.Patients receiving any other probiotic therapy or who have used probiotics in the last 1 week. 6.Patients with a history of allergic reaction to probiotics or any component of Lobun Forte
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Blood Urea Nitrogen (BUN) levelsTimepoint: At Baseline to week 12 (end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Serum Creatinine levels.Timepoint: Day 0 (Baseline) to at week 12 (End of treatment).;Change in Estimated Glomerular Filtration Rate (eGFR).Timepoint: Day 0 (Baseline) to at week 12 (End of treatment).;Change in Quality of Life (QoL) scores, as measured by a validated scale.Timepoint: Day 0 (Baseline) to at week 12 (End of treatment).;Change in severity & frequency of itching (pruritus) from baseline to end of treatment, assessed using a standardized itching severity scale.Timepoint: Day 0 (Baseline) to at week 12 (End of treatment).;Change in incidence & severity of gastrointestinal (GI) discomfort (e.g., nausea, bloating, abdominal pain) from baseline to end of treatment, assessed by patientreported outcomes or symptom diary.Timepoint: Day 0 (Baseline) to at week 12 (End of treatment).;Mean change in total appetite score.Timepoint: Day 0 (Baseline) to at week 12 (End of treatment).;Proportion of patients showing 25% or more improvement in eGFR or 25% or more reduction in serum creatinine.Timepoint: Day 0 (Baseline) to at week 12 (End of treatment). | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed