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| Name | Class |
|---|---|
| HLNatural, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLNatural Immune Cohort | Other | Observational one arm virtual study of HLNatural Immune supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLNatural Immune | Dietary Supplement | Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve. |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
|
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Inclusion Criteria:
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.
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Soynoa Rafatajah, MD | Hawthorne Effect Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawthorne Effect, Inc. | Lafayette | California | 94549 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28059453 | Background | 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. | |
| Background | Clinic, M. Vitamin C. 2017, October 18; Available from: https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932. | ||
| 16860549 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 17, 2019 | Oct 14, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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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
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| 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 | 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 | 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. | 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 | 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 |
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