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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Common Cold

Intervention / Treatment
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* Dietary Supplement: EZC Pak
* Dietary Supplement: EZC Pak +D
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |