Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicate… (NCT04032574) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis
200 participantsStarted 1991-10-08
Plain-language summary
This randomized, placebo-controlled, double-blind study investigated the efficacy and safety of the herbal medicinal product containing a combination of extracts of restharrow root (Ononidis radix), Java tea (Orthosiphonis folium) and goldenrod herb (Solidaginis herba) in women with acute lower uUTI.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion Criteria:
* Female outpatients aged 18-75 years
* Diagnosis of acute lower uUTI occurring for the first time or acute relapse of chronic recurrent uUTI
* Typical symptoms of cystitis (pollakisuria, dysuria and urgency)
* Bacterial count of 10\*4 - 10\*6 colony forming units (CFU)/mL in midstream urine
* Presence of \>20 leukocytes/µL of urine measured by dipstick test
* No antibiotic treatment required according to the investigator
* Women of childbearing potential were allowed to participate only if they used a highly effective method of contraception
* Written informed consent
Exclusion Criteria:
* Known hypersensitivity to any of the active substances or excipients of the study medication
* Antibiotic treatment during the past 8 days or indication for antibiotic treatment for the current infection
* Patients with trichomoniasis, chlamydiosis or gonorrhoea
* Use of concomitant medication that may have an effect on the UTI, including other phytotherapeutics with similar effects, saluretics (including those in antihypertensives) or other drugs with a similar mode of action, urinary acidifying agents (e.g. Acimethin®), antibiotics, or phytotherapeutics with possible antibiotic effects
* Patients with suspected ovarian inflammation (e.g. adnexitis)
* Patients with suspected renal inflammation (e.g. pyelonephritis)
* Patients with complicated UTI (e.g. obstruction, stones, reflux)
* Patients with overactive bladder
* Patients with vegetative urogenital syndrome
* Pa…