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

Sponsor

PPC Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04943575

Collaborator

Citruslabs (Industry)

360

Enrollment

Location

Arms

Actual Duration (Months)

45.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold	Dietary Supplement: EZC Pak Dietary Supplement: EZC Pak +D Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

PPC Pharmaceuticals
Citruslabs

Investigators

Principal Investigator: Susanne Mitschke, BSc, MSc, Citruslabs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PPC Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04943575

Other Study ID Numbers:

20214

First Posted:

Jun 29, 2021

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Tract Infections

Common Cold

Study Results

No Results Posted as of Apr 7, 2022