Status:
COMPLETED
Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis
Lead Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Collaborating Sponsors:
Dr. Wiedey GmbH - Institut Für Klinische Forschung
Medidata Dr. Möller GmbH
Conditions:
Urinary Tract Infection Lower Acute
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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), J...
Detailed 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), J...
Eligibility Criteria
Inclusion
- 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
- 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
- Patients who were currently participating or had participated in another clinical trial 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 further participation in the study unless they specifically wished to continue treatment with the study medication.
- No contraindications against the study medication were known at the time of study protocol preparation
Key Trial Info
Start Date :
October 8 1991
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 1992
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04032574
Start Date
October 8 1991
End Date
March 27 1992
Last Update
July 26 2019
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