Safety of Pelargonium extract EPs 7630 in young children with acute bronchitis.

ABSTRACT:

Background

The efficacy and tolerability of Pelargonium sidoides DC. root extract EPs 7630 in children with acute bronchitis (AB) have been widely demonstrated. We investigated the safety and tolerability of a syrup formulation and an oral solution in pre-school children.

Methods

In an open-label, randomized clinical trial (EudraCT number 2011-002652-14), children aged 1-5 years suffering from AB received EPs 7630 syrup or solution for 7 days. Safety was assessed by frequency, severity, and nature of adverse events (AE), vital signs, and laboratory values. Outcome measures for evaluating the health status were the intensity of coughing, pulmonary rales, and dyspnea, measured by the short version of the Bronchitis Severity Scale (BSS-ped), further symptoms of the respi

SUBMITTER: Kamin W 

PROVIDER: S-EPMC9971625 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature