RCT to evaluate the efficacy and safety of ivy leaves cough liquid

Background: Acute cough is one of the lead symptoms of respiratory diseases where ivy leaves dry extract preparations provide relief. Aims and objectives: This randomized, placebo-controlled, double-blind trial was conducted to assess the efficacy and safety of ivy leaves cough liquid in the treatment of acute cough. Methods: A total of 181 adult patients with acute cough were treated with ivy leaves cough liquid containing EA 575 ® or with placebo three times a day for a week. The primary efficacy outcome was cough severity (CS) assessed by Visual Analogue Scale (VAS) over the treatment period (area-under-the-curve (AUC 0-168 h ), visit (V)1-5). The secondary endpoints were defined as the CS assessed by VAS over the observation period (V1–V6) and by Bronchitis Severity Score (BSS) and Verbal Category Descriptive (VCD) score. Results: The evaluation of the VAS, BSS and VCD Score revealed that subjects treated with ivy leaves cough liquid showed statistically significant and clinically relevant reductions in CS compared to the placebo group. Furthermore, a remarkable early onset of efficacy was observed as significant reductions of cough severity were detected within 48 hours after the first drug intake. At all following visits and even 7 days after the end of treatment (V6) this significant treatment advantage was detected in comparison to placebo. All adverse events (AEs) in this clinical trial were non-serious and not drug-related. Also u003e65 years old patients benefitted from the very good tolerability. Conclusions: This clinical trial proved consistent superiority of the ivy leaves cough liquid treatment versus placebo and confirmed the EA 575 ® preparation to be a safe and efficacious option for the treatment of acute cough.