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

Primary Purpose

Urinary Tract Infection Lower Acute

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Herbal Medicinal Product
Placebo
Sponsored by
Medice Arzneimittel Pütter GmbH & Co KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection Lower Acute

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Herbal medicinal product

    Placebo

    Arm Description

    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

    three times daily two film coated tablets

    Outcomes

    Primary Outcome Measures

    microbiologic response
    Percentage of patients with a reduction in bacterial urine culture counts by at least 10*2 CFU/ml

    Secondary Outcome Measures

    Leukocyturia
    Percentage of patients without leukocyturia

    Full Information

    First Posted
    July 23, 2019
    Last Updated
    July 25, 2019
    Sponsor
    Medice Arzneimittel Pütter GmbH & Co KG
    Collaborators
    Dr. Wiedey GmbH - Institut Für Klinische Forschung, Medidata Dr. Möller GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04032574
    Brief Title
    Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 8, 1991 (Actual)
    Primary Completion Date
    March 27, 1992 (Actual)
    Study Completion Date
    March 27, 1992 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medice Arzneimittel Pütter GmbH & Co KG
    Collaborators
    Dr. Wiedey GmbH - Institut Für Klinische Forschung, Medidata Dr. Möller GmbH

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Tract Infection Lower Acute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Herbal medicinal product
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    three times daily two film coated tablets
    Intervention Type
    Combination Product
    Intervention Name(s)
    Herbal Medicinal Product
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    microbiologic response
    Description
    Percentage of patients with a reduction in bacterial urine culture counts by at least 10*2 CFU/ml
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Leukocyturia
    Description
    Percentage of patients without leukocyturia
    Time Frame
    7 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roland Fischer, PhD
    Organizational Affiliation
    Medice Arzneimittel Pütter GmbH & CoKG
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31817885
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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