NCT04032574

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Medice Arzneimittel Pütter GmbH & Co KG · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Herbal Medicinal Product
OTHER	Placebo

Timeline

• Start date: 1991-10-08
• Primary completion: 1992-03-27
• Completion: 1992-03-27
• First posted: 2019-07-25
• Last updated: 2019-07-26