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

NCT04943575 | Completed

• 1 other identifier: 20214
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Intervention 1

ACTIVE COMPARATOR

EZC Pak

Dietary Supplement: EZC Pak

Intervention 2

ACTIVE COMPARATOR

EZC Pak+D

Dietary Supplement: EZC Pak +D

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

EZC Pak 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 1

EZC Pak +D 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.

Intervention 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PPC Pharmaceuticals: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Related Publications (1)

• 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.

  PMID: 37163146 DERIVED

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Susanne Mitschke, BSc, MSc

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: June 1, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)