Evaluating the Utility of EZC Pak, a 5-Day Combination Echinacea-Zinc-Vitamin C Dose Pack with or without Vitamin D, in the Management of Outpatient Upper Respiratory Infections: An Initial Randomized Double-Blind Placebo-Controlled Clinical Trial

BackgroundGrowing antibiotic resistance is among the most serious threats to healthcare systems and public health globally with antibiotic misuse considered a leading driver of this problem. One of the largest areas of antibiotic misuse is in outpatient upper respiratory infections (URIs), the most common infection in humans. The purpose of this research is to evaluate the efficacy of EZC Pak, a combination Echinacea-Zinc-Vitamin C dose pack with or without Vitamin D, on the duration of illness and symptom severity of non-specific URIs as an alternative to antibiotics when none are deemed clinically necessary. A secondary analysis was carried out on patient satisfaction with using EZC Pak. MethodsA total of 360 patients across the United States were enrolled and randomized in a double-blind manner across two intervention groups, EZC Pak, EZC Pak+Vitamin D, and one placebo group. The study was conducted virtually utilizing a smartphone-based app to screen, enroll and capture study data of the participants. Once a study participant reported the first symptoms of a URI, they were advised to take the intervention as directed and complete the daily symptom survey score until their symptoms resolved. ResultsThe average EZC Pak participant recovered 1.39 days faster than placebo (p = 0.017) than the average placebo participant. The average EZC Pak participant reported a 17.43% lower symptom severity score versus placebo (p = 0.029). EZC Pak users reported 2.9 times higher patient satisfaction versus users of the placebo (p = 0.012). The addition of Vitamin D during this acute phase of illness neither benefited nor harmed illness duration or symptom severity. ConclusionsThe findings support the potential use of EZC Pak as a viable alternative to patient request for antibiotics when none are deemed clinically necessary at the time of initial clinical presentation. The decision to replete vitamin D in the acute phase of URI is an individualized decision left to the patient and their clinician. EZC Pak may play a critical role in improving outpatient URI management and antibiotic stewardship. (ClinicalTrials.gov number, NCT04943575.)