Treatment with EPs 7630, a Pelargonium Sidoides Root Extract, Is Effective and Safe in Patients with the Common Cold: Results From a Randomized, Double Blind, Placebo-Controlled Clinical Trial.
Year: 2019
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: EPs 7630 was shown to be effective and safe in the treatment of acute respiratory tract infections such as acute bronchitis, acute rhinosinusitis, and acute tonsillopharyngitis. A clinical trial was conducted to investigate its efficacy and safety in the common cold. METHODS: In this multicenter, randomized, double-blind phase 3 clinical trial, 105 adults suffering from common cold symptoms were randomized to a thrice-daily administration of either 1 film-coated tablet containing 40 mg EPs 7630 or matched placebo for a treatment period of 10 days. The primary outcome measure was the sum of differences in the cold intensity score (CIS) from day 1 to day 5, defined as the Sum of the Symptom Intensity Differences (SSID), indicating the degree of symptom improvement in the course of 5 days of treatment. Among the secondary outcomes were clinical cure defined as (a) complete resolution of all cold symptoms (CIS = 0 points) or (b) complete resolution of all or all but one cold symptom, treatment outcome, satisfaction with treatment, and safety parameters. RESULTS: values ≤ .0002). During the clinical trial, adverse events occurred in 5 patients (9.4%) in the EPs 7630 and in 7 (13.5%) in the placebo group. All adverse events were of mild intensity, with the exception of 3 events in the placebo group, which were classified as moderate. CONCLUSIONS: Treatment with EPs 7630 was shown to be superior to placebo in patients with the common cold indicating faster reduction of symptom intensity and distinctly more pronounced effects achieved by administration of the investigational drug in patients suffering from the common cold. Results extend previous findings on efficacy, safety, and tolerability of this active substance.
Source: PubMed
Authors: David S Riley, Viktor G Lizogub, Marianne Heger, Petra Funk, Heiko Mueller, Walter Lehmacher
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W3016119565