Clinical trial NCT04103099: Impact of HLNatural Immune Supplement on Colds
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System Diseases
Lead sponsor: Hawthorne Effect Inc.
Sponsor class: OTHER
Collaborators: name: HLNatural, Inc.
First posted: 2019-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: OTHER

Brief 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. 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.

1. Complete the screening survey.
2. Sign the eConsent if approved.
3. Complete the baseline survey, demographic form, and Medication and Supplements form.
4. Receive test product and log into study portal and complete supplement receipt form. This will mark the start of your participation in this study.
5. Once you have a cold, complete the symptom survey.
6. Take test product.
7. Write down any adverse or ill effects any time after taking the test product.
8. Record if you took any additional medications or supplements daily during the course of your cold.
9. Note any final adverse events and complete the exit form.

Eligibility criteria: 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:

  * 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
  * 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

Primary outcomes:
measure: Outcome of freedom of cold symptoms while consuming HLNatural Supplement
timeFrame: At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve.
Secondary outcomes:
measure: Outcome of the severity of cold symptoms while taking HLNatural Supplement
timeFrame: The diary will be completed daily during the duration of the the subject's cold.
measure: Outcome of the duration of the cold symptoms while taking HLNatural Supplement
timeFrame: At the onset of cold symptoms until resolution of cold symptoms
measure: Required Behavior
timeFrame: During the duration of the cold symptoms
measure: Outcome all adverse events while taking HLNatural Supplement
timeFrame: Throughout the study
measure: Outcome of natural behavior of the participants while taking in the clinical trial
timeFrame: 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
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Hawthorne Effect, Inc.
state: California
Study officials:
affiliation: Hawthorne Effect Inc.
name: Soynoa Rafatajah, MD
role: PRINCIPAL_INVESTIGATOR
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