Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)

A randomized-controlled interventional clinical trial to evaluate the effectiveness of EZC Pak & EZC Pak+D for the treatment of the common cold and/or a URI.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Dietary supplement: EZC Pak; Dietary supplement: EZC Pak +D; Dietary supplement: Placebo

Detailed Description

This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the efficacy of PPC Pharmaceuticals EZC Pak (& EZC Pak+D) to improve the severity and duration of the common cold or a URI in individuals. It is hypothesized that study participants will experience a positive impact on the duration and severity of their cold/URI while using EZC Pak (&EZC Pak+D). The second study objective is to examine if patients are accepting the test product as an alternative to antibiotics.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female over 18 years old
• Must be in good health (don't report any medical conditions asked in the screening questionnaire)
• Seeking OTC remedies to reduce the severity and duration of their common cold symptoms, when they arise
• Must have a thermometer at home
• Must have a blood pressure monitor at home
• Ideally, uses one of the following devices: Apple Watch, Oura Ring, FitBit, other fitness trackers

Exclusion Criteria:

• Unwilling to try the test product for their cold

• Has any of the following medical conditions:

  • ragweed or daisy allergy
  • chronic seasonal allergies
  • liver disease
  • autoimmune or connective tissue disorder (e.g., rheumatoid arthritis, lupus, multiples sclerosis, HIV)
  • alcohol consumption more than 7 drinks per week, or more than 3 drinks per occasion
  • IV drug use
  • renal disease
  • females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; After the onset of common cold symptoms, participants will take one pill (Placebo) each day for a period of 5 days.
Active Comparator: Intervention 1; EZC Pak	Dietary supplement: EZC Pak; After the onset of common cold symptoms, participants will take one pill (EZC Pak) each day for a period of 5 days.
Active Comparator: Intervention 2; EZC Pak+D	Dietary supplement: EZC Pak +D; After the onset of common cold symptoms, participants will take one pill (EZC Pak +D) each day for a period of 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective: Reduction in severity of common cold symptoms	The primary objective of this study is to understand if EZC Pak (and EZC Pak +D) changes the severity and duration of an upper respiratory illness (URI) compared to a placebo. The study uses a scale of 1-4 (no symptoms to severe symptoms) to assess the effectiveness of the intervention.	6 months

Collaborators and Investigators

• Sponsor: PPC Pharmaceuticals
• Collaborators: Citruslabs
• Investigators: Principal Investigator: Susanne Mitschke, BSc, MSc, Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Picornaviridae Infections; Respiratory Tract Infections; Common Cold
• Other Study ID Numbers: 20214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No