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

PPC Pharmaceuticals

Status: Completed

Conditions: Common Cold

Treatments: Dietary Supplement: EZC Pak; Dietary Supplement: EZC Pak +D; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04943575

20214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 3 patient groups, including a placebo group

Intervention 1

Active Comparator group

Description:

EZC Pak

Treatment:

Dietary Supplement: EZC Pak

Intervention 2

Active Comparator group

Description:

EZC Pak+D

Treatment:

Dietary Supplement: EZC Pak +D

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo