AquUTI: Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis
Study Details
Study Description
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), Java tea (Orthosiphonis folium) and goldenrod herb (Solidaginis herba) in women with acute lower uUTI.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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), 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Herbal medicinal product three times daily two film coated tablets containing: extracts of restharrow root (Ononidis radix) 80mg,Java tea (Orthosiphonis folium) 90mg, goldenrod herb (Solidaginis herba) 180mg |
Combination Product: Herbal Medicinal Product
|
| Placebo Comparator: Placebo three times daily two film coated tablets |
Other: Placebo
|
Outcome Measures
Primary Outcome Measures
- microbiologic response [7 days]
Percentage of patients with a reduction in bacterial urine culture counts by at least 10*2 CFU/ml
Secondary Outcome Measures
- Leukocyturia [7 days]
Percentage of patients without leukocyturia
Eligibility Criteria
Criteria
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 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 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
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Patients with suspected ovarian inflammation (e.g. adnexitis)
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Patients with suspected renal inflammation (e.g. pyelonephritis)
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Patients with complicated UTI (e.g. obstruction, stones, reflux)
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Patients with overactive bladder
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Patients with vegetative urogenital syndrome
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Patients who were currently participating or had participated in another clinical trial within 30 days before enrolment
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Patients in poor general condition
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Alcohol- or drug-addicted patients
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medice Arzneimittel Pütter GmbH & Co KG
- Dr. Wiedey GmbH - Institut Für Klinische Forschung
- Medidata Dr. Möller GmbH
Investigators
- Study Director: Roland Fischer, PhD, Medice Arzneimittel Pütter GmbH & CoKG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 97.019/91