Common Cold
Conditions
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.
Interventions
DIETARY_SUPPLEMENTEZC Pak
After the onset of common cold symptoms, participants will take one pill (EZC Pak) each day for a period of 5 days.
DIETARY_SUPPLEMENTEZC 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.
DIETARY_SUPPLEMENTPlacebo
After the onset of common cold symptoms, participants will take one pill (Placebo) each day for a period of 5 days.
Sponsors
Citruslabs
PPC Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed