Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: CV-HFU01 Tablets: V-HFU01 is a polyherbal formulation useful in management of UTI and related symptoms. 1 Tablet is to be consumed twice daily after meal for at least 3 months.
Sponsors
Climic Health Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients of age 18 to 60 (both inclusive) 2.Patients with subclinical (asymptomatic bacteriuria) and or recurrent UTI (2-3 episodes of UTI in the last 12 months) 3.Patients with or without UTI not responding to antimicrobial therapy due to any cause including multidrug resistance. 4.Patients prone to recurrent UTIs [like geriatric women, geriatric men with symptomatic BPH, patients on clean intermittent catheterization (CIC), chronically catheterized patients (indwelling catheter, supra pubic catheter) patients with spinal cord injury/ stroke/ paraplegia/ abnormalities of urinary tract]. 5.Patients with subclinical (asymptomatic)/recurrent UTI who are off any antibiotics for the past two weeks. The working definition of recurrent UTI used by us for this study: Patients with recurrent UTI ( > 2 or equal to episodes) who had culture positive/sensitive UTI and had taken multiple courses of antimicrobials in the past one year or so and desiring alternative therapy were given the option of entering in to this study
Exclusion criteria
Exclusion criteria: 1. Patients with the first episode of symptomatic active UTI 2. Pregnant and or lactating patients. 3. Patients in the pediatric age group. 4. Patients with known history of hyperoxaluria/known renal oxalatestone formers. 6. Patients not consenting for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate mean percentage change in symptoms like 1.Burning micturition 2.Intermittent urination 3.Pain during urination 4. Other symptoms of UTITimepoint: Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Patients Global Assessment, Physicians global Assessment 2.To assess the safety of CV-HFU01 tablets by observing adverse events 3.To evaluate tolerability and safety of CV-HFU01 tablets in patients with recurrent UTI. Timepoint: Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) | — |
Countries
India
Contacts
Public ContactMr Prateek Shastrakar
climic health pvt ltd
Outcome results
None listed