Immune System DiseasesNCT04103099
Impact of HLNatural Immune Supplement on Colds
A study testing HLNatural Immune in people with Immune System Diseases, run by Hawthorne Effect Inc. at 1 site in United States.
Trial summary
According to the Centers of Disease Control and Prevention (CDC) adults will have an average of 2-3 colds per year. Most colds will last approximately 7-10 days. The symptoms of colds could include cough, sore throat, runny nose, body aches, fevers, headaches and fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune System Diseases
- What is being tested?
- HLNatural Immune
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 15 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult candidates in the general population who are in good health and are seeking herbal remedies to reduce the duration of their common cold symptoms when they should arise. Participants will be deemed to be in good health if they do not report any of the medical conditions asked about in the screening questionnaire.
Who cannot join
- Age < 18 years old
- Unwilling to try the test product during their first cold experience in the trial
- Has any of the following medical conditions:
- Chronic seasonal allergies
- Allergy to any of the following ingredients: Echinacea, Ivy Extract, Camu Camu, Vitamin C, Ginger, Turmeric, Zinc or a known allergy to Guar Gum, Monk Fruit, Citric Acid, Natural Flavors.
- Asthma
Show all 15Show fewer
- Current cold infection
- Currently taking antimicrobial or antiviral medication
- Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion
- Routine recreational drug use
- Chronic renal disease
- Chronic liver disease
- Known autoimmune or immunodeficiency disorders
- Medically treated atopy or allergy
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the HLNatural, Inc. Immune Support Product in Reducing the Length of Cold Symptoms in Adults Suffering From the Common Cold
According to the Centers of Disease Control and Prevention (CDC) adults will have an average of 2-3 colds per year. Most colds will last approximately 7-10 days. The symptoms of colds could include cough, sore throat, runny nose, body aches, fevers, headaches and fatigue. A cold can affect your activity such as going to work, interrupting your sleep and your day to day activities. The test product contains all natural ingredients which have been combined into a powder to be taken in water at the sign of a cold.
Read the detailed description
At the onset of a cold, mix 1 packet of the drink-mix product in 6-8 oz. of hot water. Drink the drink mix twice a day until symptoms are gone or 18 days, whichever comes first.
- Complete the screening survey.
- Sign the eConsent if approved.
- Complete the baseline survey, demographic form, and Medication and Supplements form.
- Receive test product and log into study portal and complete supplement receipt form. This will mark the start of your participation in this study.
- Once you have a cold, complete the symptom survey.
- Take test product.
- Write down any adverse or ill effects any time after taking the test product.
- Record if you took any additional medications or supplements daily during the course of your cold.
- Note any final adverse events and complete the exit form.
- Conditions
- Immune System Diseases
- Being tested
- HLNatural Immune
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLNatural ImmuneDietary supplement
Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water
| Study group | Role | What they receive |
|---|---|---|
| HLNatural Immune Cohort | Other | Observational one arm virtual study of HLNatural Immune supplement Receives: Dietary Supplement: HLNatural Immune |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of freedom of cold symptoms while consuming HLNatural Supplement
Cold symptoms will be measured until the symptoms resolve. Subjects must experience 2 of more symptoms which are: cough, hoarseness, muscle aches, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, or an oral temperature of 37.7 C (99.9 F).
Measured: At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve.
Secondary outcomes (5)
Outcome of the severity of cold symptoms while taking HLNatural Supplement
Subjects will rate the severity of the cold symptoms using Daily Symptom Survey of each possible symptom from 0-3 (3 is severe).
- Comparison against the participant's normal behavior.
- Net Promoter Score.
- Adverse events will be summarized.
- An additional data presentation will consist of results from both Treatment and Control in similar studies appearing in the literature. There will be no formal statistical comparison of results from this study and historical studies.
Measured: The diary will be completed daily during the duration of the the subject's cold.
Outcome of the duration of the cold symptoms while taking HLNatural Supplement
The length of time that the subject's cold will be recorded
Measured: At the onset of cold symptoms until resolution of cold symptoms
Required Behavior
Subjects will be asked to avoid over the counter cold-relief medication. However pain relievers and fever reducers are allowed
Measured: During the duration of the cold symptoms
Outcome all adverse events while taking HLNatural Supplement
All adverse events which are collected throughout the subjects participation will be recorded.
Measured: Throughout the study
Outcome of natural behavior of the participants while taking in the clinical trial
All subjects will be asked to complete a screening, demographic and baseline questionnaire as well as and exit survey. The screening and baseline survey will be used to understand the subjects normal behavior with cold symptoms. The Exit study will rate the product to understand if the subject felt it helped with their cold symptoms
Measured: The subject will complete the screening, demographic and baseline surveys prior to the start of the product and the exit form at the end of the subject's cold symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start16 Oct 2019
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Immune System DiseasesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The present study will be a single site, prospective, single arm observational study of minimal risk consisting of at least 200 participants who suffer from cold symptoms
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawthorne Effect Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- HLNatural, Inc.
- Responsible party
- Sponsor
- Investigators
- Soynoa Rafatajah, MD, Principal investigator, Hawthorne Effect Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103099
- Sponsor's protocol ID
- Pro00037635
- Status last verified
- Nov 2021
- First submitted
- 13 Sep 2019
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdollahi E, Momtazi AA, Johnston TP, Sahebkar A. Therapeutic effects of curcumin in inflammatory and immune-mediated diseases: A nature-made jack-of-all-trades? J Cell Physiol. 2018 Feb;233(2):830-848. doi: 10.1002/jcp.25778. Epub 2017 Mar 31.
PubMed 28059453Clinic, M. Vitamin C. 2017, October 18; Available from: https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932.
Fazio S, Pouso J, Dolinsky D, Fernandez A, Hernandez M, Clavier G, Hecker M. Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: a prospective, open, multicentre postmarketing study in 9657 patients. Phytomedicine. 2009 Jan;16(1):17-24. doi: 10.1016/j.phymed.2006.05.003. Epub 2006 Jul 24.
PubMed 16860549Fonseca FN, Papanicolaou G, Lin H, Lau CB, Kennelly EJ, Cassileth BR, Cunningham-Rundles S. Echinacea purpurea (L.) Moench modulates human T-cell cytokine response. Int Immunopharmacol. 2014 Mar;19(1):94-102. doi: 10.1016/j.intimp.2013.12.019. Epub 2014 Jan 13.
PubMed 24434371Fulgoni VL 3rd, Keast DR, Bailey RL, Dwyer J. Foods, fortificants, and supplements: Where do Americans get their nutrients? J Nutr. 2011 Oct;141(10):1847-54. doi: 10.3945/jn.111.142257. Epub 2011 Aug 24.
PubMed 21865568Gammoh NZ, Rink L. Zinc in Infection and Inflammation. Nutrients. 2017 Jun 17;9(6):624. doi: 10.3390/nu9060624.
PubMed 28629136Grosso G, Bei R, Mistretta A, Marventano S, Calabrese G, Masuelli L, Giganti MG, Modesti A, Galvano F, Gazzolo D. Effects of vitamin C on health: a review of evidence. Front Biosci (Landmark Ed). 2013 Jun 1;18(3):1017-29. doi: 10.2741/4160.
PubMed 23747864Hemila H, Petrus EJ, Fitzgerald JT, Prasad A. Zinc acetate lozenges for treating the common cold: an individual patient data meta-analysis. Br J Clin Pharmacol. 2016 Nov;82(5):1393-1398. doi: 10.1111/bcp.13057. Epub 2016 Jul 28.
PubMed 27378206Hilding DA. Literature review: the common cold. Ear Nose Throat J. 1994 Sep;73(9):639-43, 46-7.
PubMed 7988393Hudson JB. Applications of the phytomedicine Echinacea purpurea (Purple Coneflower) in infectious diseases. J Biomed Biotechnol. 2012;2012:769896. doi: 10.1155/2012/769896. Epub 2011 Oct 26.
PubMed 22131823Jawad M, Schoop R, Suter A, Klein P, Eccles R. Safety and Efficacy Profile of Echinacea purpurea to Prevent Common Cold Episodes: A Randomized, Double-Blind, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2012;2012:841315. doi: 10.1155/2012/841315. Epub 2012 Sep 16.
PubMed 23024696Lang C, Rottger-Luer P, Staiger C. A Valuable Option for the Treatment of Respiratory Diseases: Review on the Clinical Evidence of the Ivy Leaves Dry Extract EA 575(R). Planta Med. 2015 Aug;81(12-13):968-74. doi: 10.1055/s-0035-1545879. Epub 2015 Apr 15.
PubMed 25875509Langley PC, Pergolizzi JV Jr, Taylor R Jr, Ridgway C. Antioxidant and associated capacities of Camu camu (Myrciaria dubia): a systematic review. J Altern Complement Med. 2015 Jan;21(1):8-14. doi: 10.1089/acm.2014.0130. Epub 2014 Oct 2.
PubMed 25275221Lopresti AL, Hood SD, Drummond PD. Multiple antidepressant potential modes of action of curcumin: a review of its anti-inflammatory, monoaminergic, antioxidant, immune-modulating and neuroprotective effects. J Psychopharmacol. 2012 Dec;26(12):1512-24. doi: 10.1177/0269881112458732. Epub 2012 Oct 3.
PubMed 23035031Matthias A, Banbury L, Stevenson LM, Bone KM, Leach DN, Lehmann RP. Alkylamides from echinacea modulate induced immune responses in macrophages. Immunol Invest. 2007;36(2):117-30. doi: 10.1080/08820130600745786.
PubMed 17365014
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the HLNatural, Inc. Immune Support Product in Reducing the Length of Cold Symptoms in Adults Suffering From the Common Cold
- ClinicalTrials.gov ID
- NCT04103099
- Acronym / sponsor ID
- Pro00037635
- Conditions
- Immune System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hawthorne Effect Inc.University, hospital or other
- Collaborators
- HLNatural, Inc.
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 25 Sep 2019 (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.
According to the Centers of Disease Control and Prevention (CDC) adults will have an average of 2-3 colds per year. Most colds will last approximately 7-10 days. The symptoms of colds could include cough, sore throat, runny nose, body aches, fevers, headaches and fatigue. A cold can affect your activity such as going to work, interrupting your sleep and your day to day activities. The test product contains all natural ingredients which have been combined into a powder to be taken in water at the sign of a cold.
Detailed description
At the onset of a cold, mix 1 packet of the drink-mix product in 6-8 oz. of hot water. Drink the drink mix twice a day until symptoms are gone or 18 days, whichever comes first.
- Complete the screening survey.
- Sign the eConsent if approved.
- Complete the baseline survey, demographic form, and Medication and Supplements form.
- Receive test product and log into study portal and complete supplement receipt form. This will mark the start of your participation in this study.
- Once you have a cold, complete the symptom survey.
- Take test product.
- Write down any adverse or ill effects any time after taking the test product.
- Record if you took any additional medications or supplements daily during the course of your cold.
- Note any final adverse events and complete the exit form.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The present study will be a single site, prospective, single arm observational study of minimal risk consisting of at least 200 participants who suffer from cold symptoms
| Arm | Type | Receives |
|---|---|---|
| HLNatural Immune Cohort | Other | Dietary Supplement: HLNatural ImmuneObservational one arm virtual study of HLNatural Immune supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult candidates in the general population who are in good health and are seeking herbal remedies to reduce the duration of their common cold symptoms when they should arise. Participants will be deemed to be in good health if they do not report any of the medical conditions asked about in the screening questionnaire.
Key exclusion criteria (15 listed)
- Age < 18 years old
- Unwilling to try the test product during their first cold experience in the trial
- 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 |
|---|---|---|
| HLNatural ImmuneVitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water | Dietary supplement | HLNatural Immune Cohort |
Primary outcome
Outcome of freedom of cold symptoms while consuming HLNatural Supplement
Time frame: At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve.
Cold symptoms will be measured until the symptoms resolve. Subjects must experience 2 of more symptoms which are: cough, hoarseness, muscle aches, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, or an oral temperature of 37.7 C (99.9 F).
5 secondary outcomes
Outcome of the severity of cold symptoms while taking HLNatural Supplement
Time frame: The diary will be completed daily during the duration of the the subject's cold.
Outcome of the duration of the cold symptoms while taking HLNatural Supplement
Time frame: At the onset of cold symptoms until resolution of cold symptoms
Required Behavior
Time frame: During the duration of the cold symptoms
Outcome all adverse events while taking HLNatural Supplement
Time frame: Throughout the study
Outcome of natural behavior of the participants while taking in the clinical trial
Time frame: The subject will complete the screening, demographic and baseline surveys prior to the start of the product and the exit form at the end of the subject's cold symptoms
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 15 Nov 2021.
- Background: PubMed 28059453Abdollahi E, Momtazi AA, Johnston TP, Sahebkar A. Therapeutic effects of curcumin in inflammatory and immune-mediated diseases: A nature-made jack-of-all-trades? J Cell Physiol. 2018 Feb;233(2):830-848. doi: 10.1002/jcp.25778. Epub 2017 Mar 31.
- BackgroundClinic, M. Vitamin C. 2017, October 18; Available from: https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932.
- Background: PubMed 16860549Fazio S, Pouso J, Dolinsky D, Fernandez A, Hernandez M, Clavier G, Hecker M. Tolerance, safety and efficacy of Hedera helix extract in inflammatory bronchial diseases under clinical practice conditions: a prospective, open, multicentre postmarketing study in 9657 patients. Phytomedicine. 2009 Jan;16(1):17-24. doi: 10.1016/j.phymed.2006.05.003. Epub 2006 Jul 24.
- Background: PubMed 24434371Fonseca FN, Papanicolaou G, Lin H, Lau CB, Kennelly EJ, Cassileth BR, Cunningham-Rundles S. Echinacea purpurea (L.) Moench modulates human T-cell cytokine response. Int Immunopharmacol. 2014 Mar;19(1):94-102. doi: 10.1016/j.intimp.2013.12.019. Epub 2014 Jan 13.
- Background: PubMed 21865568Fulgoni VL 3rd, Keast DR, Bailey RL, Dwyer J. Foods, fortificants, and supplements: Where do Americans get their nutrients? J Nutr. 2011 Oct;141(10):1847-54. doi: 10.3945/jn.111.142257. Epub 2011 Aug 24.
- Background: PubMed 28629136Gammoh NZ, Rink L. Zinc in Infection and Inflammation. Nutrients. 2017 Jun 17;9(6):624. doi: 10.3390/nu9060624.
- Background: PubMed 23747864Grosso G, Bei R, Mistretta A, Marventano S, Calabrese G, Masuelli L, Giganti MG, Modesti A, Galvano F, Gazzolo D. Effects of vitamin C on health: a review of evidence. Front Biosci (Landmark Ed). 2013 Jun 1;18(3):1017-29. doi: 10.2741/4160.
- Background: PubMed 27378206Hemila H, Petrus EJ, Fitzgerald JT, Prasad A. Zinc acetate lozenges for treating the common cold: an individual patient data meta-analysis. Br J Clin Pharmacol. 2016 Nov;82(5):1393-1398. doi: 10.1111/bcp.13057. Epub 2016 Jul 28.
- Background: PubMed 7988393Hilding DA. Literature review: the common cold. Ear Nose Throat J. 1994 Sep;73(9):639-43, 46-7.
- Background: PubMed 22131823Hudson JB. Applications of the phytomedicine Echinacea purpurea (Purple Coneflower) in infectious diseases. J Biomed Biotechnol. 2012;2012:769896. doi: 10.1155/2012/769896. Epub 2011 Oct 26.
- Background: PubMed 23024696Jawad M, Schoop R, Suter A, Klein P, Eccles R. Safety and Efficacy Profile of Echinacea purpurea to Prevent Common Cold Episodes: A Randomized, Double-Blind, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2012;2012:841315. doi: 10.1155/2012/841315. Epub 2012 Sep 16.
- Background: PubMed 25875509Lang C, Rottger-Luer P, Staiger C. A Valuable Option for the Treatment of Respiratory Diseases: Review on the Clinical Evidence of the Ivy Leaves Dry Extract EA 575(R). Planta Med. 2015 Aug;81(12-13):968-74. doi: 10.1055/s-0035-1545879. Epub 2015 Apr 15.
- 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.
Soynoa Rafatajah, MD principal investigator
Hawthorne Effect Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLNatural Immune in people with Immune System Diseases, run by Hawthorne Effect Inc. 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 1 inclusion and 15 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 15 Nov 2021. 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. 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?
Outcome of freedom of cold symptoms while consuming HLNatural Supplement (time frame: At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve.). 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 NCT04103099, which also lists 39 linked publications.
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 15 Nov 2021.