Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Tab.Renadyl: The study drug Renadyl is to be administered as 1 capsule twice daily immediately after food for 6 months period
Control Intervention1: nil: nil
Sponsors
Dr Vandana Godella
Eligibility
Inclusion criteria
Inclusion criteria: 1.Either gender >18 to 2.Subjects diagnosed with CKD and have been stable for at least 3 months 3.Serum creatinine levels greater than 2.5 mg/dL at the time of screening. 4. Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study 5. Willing to sign the written informed consent prior to inclusion in the study at the time of screening.
Exclusion criteria
Exclusion criteria: 1.Pregnant or Nursing women, 2.Antibiotic treatment at the time of screening or within 14 days before screening 3.H/o of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or Hepatitis C in the last 6 months. 4.Active dependency on controlled substances and alcohol 5.Administration of an investigational drug either currently or within 30 days of screening. 6.Active addictive drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment. 7.Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint. 8.Pre-existing cardiac or pulmonary or hepatic or neurological co-morbidities which in the judgement of the Nephrologist would interfere with the study. 9.Subjects with social conditions or medical debilitating disease/disorder, which, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent or affect overall prognosis of the Subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Uremic toxins plasma levels: Changes in indoxyl sulfate, p-cresyl sulfate and indole-3- acetic acid from baseline are recorded. 2. Changes in Renal function tests (Serum urea, creatinine and uric acid) from baseline. Timepoint: every 30 days for 6 months after enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of Life (QoL) SF 8 Questionnaire score 2. hs CRP, IL-6, TNF-α (Inflammatory Biomarkers) 3. NO, MDA, GSH (Biomarkers of Oxidative stress) 4. Estimated Glomerular Filtration (eGFR) 5.Evaluation of safety of study drugsTimepoint: every 30 days for 6 months after enrollment | — |
Countries
India
Contacts
Public ContactDrCPrabhakar Reddy
Nizams Institute of Medical Sciences
Outcome results
None listed