The study to evaluate the efficacy and safety of DAPAD COMPLEX dietary supplement as an adjuvant therapy in treatment of uncomplicated acute urinary tract infections (UTI)
- Conditions
- Health Condition 1: N390- Urinary tract infection, site notspecified
- Registration Number
- CTRI/2021/03/032136
- Lead Sponsor
- Giellepi SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Adult Female Fertile age
Age � 18 years to 45 years
Written informed consent
At least one of four key UTI symptoms that could be attributed to an uncomplicated UTI, and no alternative explanation (i.e. symptoms suggestive of STI or vulvo-vaginitis):
Dysuria
Urgency (including nocturia)
Frequency
Suprapubic tenderness
Urine culture positive for E.Coli �105 cfu/mL
1.Male sex
2.Urine culture positive to uropathogens different from E. coli
3.Pregnancy or planned pregnancy
4.Concomitant antimicrobial therapy at the time of screening
5.Use of any antibiotics in the past 7 days
6.Use of dietary supplements (such as cranberry, probiotics, etc) during the month before recruitment
7.Known or suspected hypersensitivity or allergy to any ingredient of Investigational product
8.Active upper UTI (e.g. pyelonephritis, urosepsis: fever > 38.0, flank pain, chills)
9.Symptoms/signs suggestive of vaginitis or sexually transmitted infection
10.Indwelling catheter, nephrostomy, ureter stent or other foreign material
11.Otherwise complicated UTI:
�A history of anatomical or functional abnormalities of the urogenital tract:
�Congenital abnormalities
�Polycystic kidney disease
�Obstruction or stricture of renal pelvis, ureter or urethra
�Kidney stones
�Cystocele
�Cystic diverticulae
�Change of anatomical proportions (e.g. after ureter implantation)
�Chronic vesico-urethral reflux
�Neurogenic bladder
12.Severe chronic renal (creatinine clearance < 30 ml/min) or hepatic dysfunction
13.Diagnosis of diabetes
14.Immunosuppression:
�Untreated infection with the human immunodeficiency virus (HIV)
�Use of high-dose systemic corticosteroids or other immunosuppressive medication
�Chemotherapy
�Treatment with radiation
15.Critical illness requiring intensive care
16.Planned surgery within the next 6 weeks
17.Pelvic or gynecological surgery during the 6 months before recruitment
18.Inability to take oral drugs
19.Participation in another prospective clinical trial
20.Previous enrolment in the proposed study
21.Inability to understand or to follow the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical response at the end of treatment (day 6 �±2 days) and one month after the end of therapy.Timepoint: (day 6 �±2 days) and one month after the end of therapy.
- Secondary Outcome Measures
Name Time Method bacteriologic response at the end of therapyTimepoint: day 6 �±2 days and one month after the end of therapy