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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection Lower Acute
• Intervention / Treatment: Other: Placebo; Combination product: Herbal Medicinal Product

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
microbiologic response	Percentage of patients with a reduction in bacterial urine culture counts by at least 10*2 CFU/ml	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leukocyturia	Percentage of patients without leukocyturia	7 days

Collaborators and Investigators

• Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Collaborators: Dr. Wiedey GmbH - Institut Für Klinische Forschung; Medidata Dr. Möller GmbH
• Investigators: Study Director: Roland Fischer, PhD, Medice Arzneimittel Pütter GmbH & CoKG

Publications and helpful links

General Publications

• Vahlensieck W, Lorenz H, Schumacher-Stimpfl A, Fischer R, Naber KG. Effect of a Herbal Therapy on Clinical Symptoms of Acute Lower Uncomplicated Urinary Tract Infections in Women: Secondary Analysis from a Randomized Controlled Trial. Antibiotics (Basel). 2019 Dec 7;8(4):256. doi: 10.3390/antibiotics8040256.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 1991
• Primary Completion (Actual): March 27, 1992
• Study Completion (Actual): March 27, 1992

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Bladder Diseases; Cystitis; Urinary Tract Infections
• Other Study ID Numbers: 97.019/91

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No