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

NCT ID: NCT04943575

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-01-30

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.

Conditions

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Common Cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention 1

EZC Pak

Group Type ACTIVE_COMPARATOR

EZC Pak

Intervention Type DIETARY_SUPPLEMENT

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

Intervention 2

EZC Pak+D

Group Type ACTIVE_COMPARATOR

EZC Pak +D

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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EZC Pak

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

PPC Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susanne Mitschke, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

Citruslabs

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

References

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Radhakrishnan A, Spencer S, Yanamala N, Malepati S. Evaluating the Efficacy and Safety of EZC Pak, a 5-Day Combination Echinacea-Zinc-Vitamin C Dose Pack with or without Vitamin D, in the Management of Outpatient Upper Respiratory Infections. Infect Drug Resist. 2023 May 3;16:2561-2572. doi: 10.2147/IDR.S392087. eCollection 2023.

Reference Type DERIVED
PMID: 37163146 (View on PubMed)

Other Identifiers

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20214

Identifier Type: -

Identifier Source: org_study_id

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