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

Urinary Tract Infection Lower Acute Clinical Trial

— AquUTI  

Official title:

Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Evaluate the Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032574
• Other study ID #: 97.019/91
• Status: Completed
• Phase: Phase 3
• Start date: October 8, 1991
• Est. completion date: March 27, 1992

Study information

• Verified date: July 2019
• Source: Medice Arzneimittel Pütter GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 27, 1992
• Est. primary completion date: March 27, 1992
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Cystitis
• Urinary Tract Infection Lower Acute
• Urinary Tract Infections

Intervention

Combination Product:
• Herbal Medicinal Product

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Medice Arzneimittel Pütter GmbH & Co KG	Dr. Wiedey GmbH - Institut Für Klinische Forschung, Medidata Dr. Möller GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbiologic response	Percentage of patients with a reduction in bacterial urine culture counts by at least 10*2 CFU/ml	7 days
Secondary	Leukocyturia	Percentage of patients without leukocyturia	7 days