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

NCT ID: NCT04032574

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1991-10-08
• Study Completion Date: 1992-03-27

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.

Conditions

Urinary Tract Infection Lower Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Herbal Medicinal Product

Intervention Type: COMBINATION_PRODUCT

Placebo

three times daily two film coated tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Herbal Medicinal Product

Intervention Type: COMBINATION_PRODUCT

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. Wiedey GmbH - Institut Für Klinische Forschung

UNKNOWN

Sponsor Role: collaborator

Medidata Dr. Möller GmbH

UNKNOWN

Sponsor Role: collaborator

Medice Arzneimittel Pütter GmbH & Co KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland Fischer, PhD

Role: STUDY_DIRECTOR

Medice Arzneimittel Pütter GmbH & CoKG

References

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.

Reference Type: DERIVED

PMID: 31817885 (View on PubMed)

Other Identifiers

97.019/91

Identifier Type: -

Identifier Source: org_study_id