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Completed

NCT Number: NCT04943575

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EZC Pak

Dietary Supplement

After the onset of common cold symptoms, participants will take one pill (EZC Pak) each day for a period of 5 days.

EZC Pak +D

Dietary Supplement

After the onset of common cold symptoms, participants will take one pill (EZC Pak +D) each day for a period of 5 days.

Placebo

Dietary Supplement

After the onset of common cold symptoms, participants will take one pill (Placebo) each day for a period of 5 days.

Primary outcomes

  1. Primary Objective: Reduction in severity of common cold symptoms

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

PPC Pharmaceuticals

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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