Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections

Summary

This is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Two newly developed and two existing Echinacea formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal 3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days or until symptom resolution. Nasopharynx samples will be collected for analysis of common viral respiratory agents throughout treatment. Safety and efficacy variables will be assessed.

Timeline

Start

2018-11-27

Primary completion

2019-06-05

Completion

2019-06-07

Outcome

Missed primary endpoint

paper The trend for faster clinical recovery was not significant by day 10 but became so upon extrapolation. PMID 37138742 ↗

paper Recovery by day 10 (complete absence of symptoms) was achieved in 56 and 44% of patients with the new and conventional formulations, respectively, showing a median time to recovery of 10 and 11 days, respectively (p = 0.10 in intention-to-treat analysis PMID 37138742 ↗

Publications

• Sumer J, Keckeis K, Scanferla G, Frischknecht M, Notter J, Steffen A, Kohler P, Schmid P, Roth B, Wissel K, Vernazza P, Klein P, Schoop R, Albrich WC. Novel Echinacea formulations for the treatment of acute respiratory tract infections in adults-A randomized blinded controlled trial. Front Med (Lausanne). 2023 Apr 17;10:948787. doi: 10.3389/fmed.2023.948787. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Echinacea purpurea alcoholic extract	Unknown	2240 mg	Oral
Subject	Echinacea purpurea alcoholic extract	Unknown	2400 mg	Oral
Subject	Echinacea purpurea alcoholic extract	Unknown	3360 mg	Oral

Indications