Clinical study to assess the usefulness of CV-HFU01 tablets in management of recurrent UTI.
- Conditions
- Urinary tract infection, site notspecified,
- Registration Number
- CTRI/2019/04/018452
- Lead Sponsor
- Climic Health Pvt Ltd
- Brief Summary
After Ethics committee’s approval, clinicalstudy will be registered on CTRI website. Subjects [(male and females agebetween 18 – 60 years, (both inclusive)] attending OPD of respective studysites without ongoing antibiotic treatment for UTI and meeting other inclusion andexclusion criteria will be recruited in the study. Intended to get 30 evaluablecases at the end of the study.
On screening visit (day -5), a writteninformed consent will be obtained from subject for his/her participation in thestudy. Subject will undergo physical and systemic examinations. Subject’smedical and surgical history will be taken. Subject’s current medication willbe noted in the CRF. Subject’s investigations [CBC, Serum uric acid LFT, RFT] willbe done. Clinical symptoms likeburning micturition, intermittent urination and pain during urinationwill be assessed. Subjects will be advised to refrain from anyNutraceutical, Ayurvedic, homeopathic, Siddha, Unani etc. treatment for thesame. Throughout study period, subjects will be advised lifestyle modification(nutritious diet, exercise etc.) The record of the current medication will bekept in the CRF. Subject will be called on baseline visit (day 0).
On baseline visit, subjects will be recruitedif he/she meets all the inclusion criteria. Subjects will undergo general andsystemic examinations. Clinical signs and symptoms (if any) will be evaluatedon subjective assessment scale, Subject will be given study medication packedin HDPE bottle (each containing 60 tablets). Subject will be advised to takestudy medication in a dose of 1 tablet twice daily orally after each meals withwater for next 90 days. Subject will be called for follow up on day 30, day 60,day 90 i.e. till end of study. Subjects who continuously misses dosing for>3 consecutive days or total missed dose >6 days during the study periodwill be treated as drop outs. Subjects will be allowed to come for follow upeither 5 days prior or after the scheduled follow up visit, provided subjectshould continue the given treatment.
On every follow up visit, subjects willundergo general and systemic examinations. Clinicalsymptoms likeburning micturition, intermittent urination and pain during urinationwill be assessed. Patient will be assessed for presence of anyadverse events.
On last follow up visit, subject’s globalevaluation for overall improvement and Investigator’s global evaluation foroverall improvement will be done. Tolerability of the study drug will beassessed by the investigator and patient at the end of the study. All the subjectswill be closely monitored for any adverse events/ adverse drug reactions from baselinevisit till the end of the study. On final follow up visit (i.e. day 90), Clinical symptoms likeburning micturition, intermittent urination and pain during urination willbe assessed. Subjectswill be asked to stop trial medication after completion of 90 days of the studytreatment and take investigator’s advice for further treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 30
- 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.
- Patients with the first episode of symptomatic active UTI 2.
- Pregnant and or lactating patients.
- Patients in the pediatric age group.
- Patients with known history of hyperoxaluria/known renal oxalatestone formers.
- Patients not consenting for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate mean percentage change in symptoms like Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) 2.Intermittent urination Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) 1.Burning micturition Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) 4. Other symptoms of UTI Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) 3.Pain during urination Screening Visit (-5 day), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90)
- Secondary Outcome Measures
Name Time Method 1.Patients Global Assessment, Physicians global Assessment 2.To assess the safety of CV-HFU01 tablets by observing adverse events
Trial Locations
- Locations (1)
Lokmanya Medical Research Centre
🇮🇳Pune, MAHARASHTRA, India
Lokmanya Medical Research Centre🇮🇳Pune, MAHARASHTRA, IndiaMs Varsha BachkarPrincipal investigator8446623333bachkarvarsha@gmail.com