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

PPC Pharmaceuticals360 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

360

Conditions

Common Cold

Interventions

EZC PakDIETARY_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 +DDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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