Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: Piperine 20 mg capsule: Piperine 20 mg capsule will be given orally followed 30 min by 500 mg of intravenous amikacin injection.
Control Intervention1: Matched Placebo capsule: Matched
Sponsors
Debasish Hota Principal investigator
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex, hospitalized with any Urinary tract infections (which is not life threatening and not admitted in ICU) receiving I.V amikacin for at least one dose 2. Age: 18-60 years 3. Creatinine clearance: 4. Patients willing to provide a written informed consent
Exclusion criteria
Exclusion criteria: Patients with significant liver and kidney disease as defined by AST / ALT > 3 times normal or Creatinine clearance (creatinine >1.5 mg/dL) 2. Significant CNS or gastrointestinal disorders 3. Patients with hearing impairment 4. Patients with neuromuscular disorders 5. Chronic smokers and alcohol users 6. Persons allergic to piperine or amikacin or any related product 7. Concomitant users of any drug inhibiting or inducing hepatic drug metabolising enzymes 8. Co-infection with HIV and Pregnancy and lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find out the change in the pharmacokinetic profile (AUC0-t, AUCt-â??, Cmax, T1/2, elimination rate constant, clearance and volume of distribution) of steady state amikacin before and after oral piperine administration.Timepoint: 5, 15, 30, 45, 60 min, 2h, 4h, 8h,12h of piperine administration | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDebasish Hota
AIIMS, BHUBANESWAR
Outcome results
None listed