Urinary Tract Infection Lower AcutePhase 3AquUTINCT04032574
Efficacy and Tolerability of a Phytotherapy Combination (Aqualibra) in Patients With Uncomplicated Cystitis
A Phase 3 study testing Herbal Medicinal Product in people with Urinary Tract Infection Lower Acute, run by Medice Arzneimittel Pütter GmbH & Co KG.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Tract Infection Lower Acute
- What is being tested?
- Herbal Medicinal Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 1991to 27 Mar 1992
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Urinary Tract Infection Lower Acute
- Being tested
- Herbal Medicinal Product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal Medicinal ProductCombination product
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Herbal medicinal product | Experimental | 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 Receives: Combination Product: Herbal Medicinal Product |
| Placebo | Placebo comparator | three times daily two film coated tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiologic response
Percentage of patients with a reduction in bacterial urine culture counts by at least 10*2 CFU/ml
Measured: 7 days
Secondary outcomes (1)
Leukocyturia
Percentage of patients without leukocyturia
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start8 Oct 1991
- Primary completion27 Mar 1992
- Study completion27 Mar 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection Lower AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Wiedey GmbH - Institut Für Klinische Forschung, Medidata Dr. Möller GmbH
- Responsible party
- Sponsor
- Investigators
- Roland Fischer, PhD, Study director, Medice Arzneimittel Pütter GmbH & CoKG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032574
- Sponsor's protocol ID
- 97.019/91
- Acronym
- AquUTI
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31817885
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04032574
- Acronym / sponsor ID
- AquUTI / 97.019/91
- Conditions
- Urinary Tract Infection Lower Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Wiedey GmbH - Institut Für Klinische Forschung, Medidata Dr. Möller GmbH
- Study start
- 8 Oct 1991 (actual)
- Primary completion
- 27 Mar 1992 (actual)
- Study completion
- 27 Mar 1992 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal medicinal product | Experimental | Combination Product: Herbal Medicinal Productthree times daily two film coated tablets containing: extracts of restharrow root (Ononidis radix) 80mg,Java tea (Orthosiphonis folium) 90mg, goldenrod herb (Solidaginis herba) 180mg |
| Placebo | Placebo comparator | Other: Placebothree times daily two film coated tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal Medicinal Product | Combination product | Herbal medicinal product |
| Placebo | Other | Placebo |
Primary outcome
microbiologic response
Time frame: 7 days
Percentage of patients with a reduction in bacterial urine culture counts by at least 10*2 CFU/ml
1 secondary outcome
Leukocyturia
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Derived from this study: PubMed 31817885Vahlensieck 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Fischer, PhD study director
Medice Arzneimittel Pütter GmbH & CoKG
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herbal Medicinal Product in people with Urinary Tract Infection Lower Acute, run by Medice Arzneimittel Pütter GmbH & Co KG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiologic response (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.