search
Back to results

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

Primary Purpose

Common Cold

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EZC Pak
EZC Pak +D
Placebo
Sponsored by
PPC Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Cold

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Intervention 1

Intervention 2

Placebo

Arm Description

EZC Pak

EZC Pak+D

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2021
Last Updated
March 30, 2022
Sponsor
PPC Pharmaceuticals
Collaborators
Citruslabs
search

1. Study Identification

Unique Protocol Identification Number
NCT04943575
Brief Title
Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
Official Title
Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PPC Pharmaceuticals
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention 1
Arm Type
Active Comparator
Arm Description
EZC Pak
Arm Title
Intervention 2
Arm Type
Active Comparator
Arm Description
EZC Pak+D
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
EZC Pak
Intervention Description
After the onset of common cold symptoms, participants will take one pill (EZC Pak) each day for a period of 5 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
EZC Pak +D
Intervention Description
After the onset of common cold symptoms, participants will take one pill (EZC Pak +D) each day for a period of 5 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
After the onset of common cold symptoms, participants will take one pill (Placebo) each day for a period of 5 days.
Primary Outcome Measure Information:
Title
Primary Objective: Reduction in severity of common cold symptoms
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Mitschke, BSc, MSc
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs