Impact of HLNatural Immune Supplement on Colds

Hawthorne Effect

Status: Completed

Conditions: Immune System Diseases

Treatments: Dietary Supplement: HLNatural Immune

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04103099

Pro00037635

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

HLNatural Immune Cohort

Other group

Description:

Observational one arm virtual study of HLNatural Immune supplement

Treatment:

Dietary Supplement: HLNatural Immune