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
Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
October 8, 1991
Actual (reported)Primary Completion
March 27, 1992
Actual (reported)Study Completion
March 27, 1992
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 27, 1992
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 1991
Actual (reported)March 27, 1992
Actual (reported)March 27, 1992
Actual (reported)July 23, 2019
Actual (reported)July 25, 2019
Actual (reported)microbiologic response
Percentage of patients with a reduction in bacterial urine culture counts by at least 10\*2 CFU/ml
7 days
Leukocyturia
7 days
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Roland Fischer, PhD
Medice Arzneimittel Pütter GmbH & CoKG
200 participants (actual enrollment reported by the registry).
First Submitted
July 23, 2019
First Posted
July 25, 2019
Study Start
October 8, 1991
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 27, 1992
Actual (reported)Study Completion
March 27, 1992
Actual (reported)Last Updated
July 26, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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