NCT04032574

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 1991

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 1991

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 1992

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 1992

Completed
27.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 23, 2019

Last Update Submit

July 25, 2019

Conditions

Urinary Tract Infection Lower Acute

Outcome Measures

Primary Outcomes (1)

  • microbiologic response

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

    7 days

Secondary Outcomes (1)

  • Leukocyturia

    7 days

Study Arms (2)

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

Combination Product: Herbal Medicinal Product

Placebo

PLACEBO COMPARATOR

three times daily two film coated tablets

Other: Placebo

Interventions

Herbal Medicinal ProductCOMBINATION_PRODUCT
Herbal medicinal product
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31817885DERIVED

Study Officials

  • Roland Fischer, PhD

    Medice Arzneimittel Pütter GmbH & CoKG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 25, 2019

Study Start

October 8, 1991

Primary Completion

March 27, 1992

Study Completion

March 27, 1992

Last Updated

July 26, 2019

Record last verified: 2019-07