Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis

Last updated: July 25, 2019
Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Overall Status: Completed

Phase

3

Condition

Urinary Incontinence

Bladder Disorders

Urinary Tract Infections

Treatment

N/A

Clinical Study ID

NCT04032574
97.019/91
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female outpatients aged 18-75 years

  • Diagnosis of acute lower uUTI occurring for the first time or acute relapse of chronicrecurrent uUTI

  • Typical symptoms of cystitis (pollakisuria, dysuria and urgency)

  • Bacterial count of 104 - 106 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 highlyeffective method of contraception

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to any of the active substances or excipients of the studymedication

  • Antibiotic treatment during the past 8 days or indication for antibiotic treatment forthe current infection

  • Patients with trichomoniasis, chlamydiosis or gonorrhoea

  • Use of concomitant medication that may have an effect on the UTI, including otherphytotherapeutics with similar effects, saluretics (including those inantihypertensives) or other drugs with a similar mode of action, urinary acidifyingagents (e.g. Acimethin®), antibiotics, or phytotherapeutics with possible antibioticeffects

  • 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

  • Patients who were currently participating or had participated in another clinicaltrial within 30 days before enrolment

  • Patients in poor general condition

  • Alcohol- or drug-addicted patients

  • Pregnant or nursing women or women not using highly effective methods of contraception

  • Patients with mental illness or no/limited legal capacity

  • Patients held in an institution by legal or official order

  • Patients who were not proficient in spoken or written German

  • Patients with a urine bacterial count >10*6 CFU/mL were to be excluded from furtherparticipation in the study unless they specifically wished to continue treatment withthe study medication.

  • No contraindications against the study medication were known at the time of studyprotocol preparation

Study Design

Total Participants: 200
Study Start date:
October 08, 1991
Estimated Completion Date:
March 27, 1992

Study Description

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 the treatment of acute lower uUTI. The herbal medicinal product represent a multi-target therapy that includes diuretic, anti-inflammatory and antimicrobial aspects.

Patients were randomized to one of the two treatment groups and treated with the phytotherapeutic agent or matching placebo for seven days.

The primary endpoint was microbiologic response defined as reduction in bacterial urine culture counts by at least 10*2 CFU/ml.