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

Common Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04943575
• Other study ID #: 20214
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2022
• Source: PPC Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
PPC Pharmaceuticals	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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