Common ColdNCT04943575
Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
A study testing EZC Pak and EZC Pak +D in people with Common Cold, run by PPC Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- EZC Pak and EZC Pak +D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Common Cold
- Being tested
- EZC Pak, EZC Pak +D, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Active comparator | EZC Pak Receives: Dietary Supplement: EZC Pak |
| Intervention 2 | Active comparator | EZC Pak+D Receives: Dietary Supplement: EZC Pak +D |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Jun 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- PPC Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Susanne Mitschke, BSc, MSc, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943575
- Sponsor's protocol ID
- 20214
- Status last verified
- Mar 2022
- First submitted
- 21 Jun 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37163146
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy of EZC Pak in Adults With Upper Respiratory Infection (URI)
- ClinicalTrials.gov ID
- NCT04943575
- Acronym / sponsor ID
- 20214
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- PPC PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Active comparator | Dietary Supplement: EZC PakEZC Pak |
| Intervention 2 | Active comparator | Dietary Supplement: EZC Pak +DEZC Pak+D |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Unwilling to try the test product for their cold
- Has any of the following medical conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EZC PakAfter the onset of common cold symptoms, participants will take one pill (EZC Pak) each day for a period of 5 days. | Dietary supplement | Intervention 1 |
| EZC Pak +DAfter the onset of common cold symptoms, participants will take one pill (EZC Pak +D) each day for a period of 5 days. | Dietary supplement | Intervention 2 |
| PlaceboAfter the onset of common cold symptoms, participants will take one pill (Placebo) each day for a period of 5 days. | Dietary supplement | Placebo |
Primary outcome
Primary Objective: Reduction in severity of common cold symptoms
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 37163146Radhakrishnan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Mitschke, BSc, MSc principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZC Pak and EZC Pak +D in people with Common Cold, run by PPC Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: Reduction in severity of common cold symptoms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.