Impact of HLNatural Immune Supplement on Colds

NCT04103099 | Completed

• 1 other identifier: Pro00037635
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Outcome of the severity of cold symptoms while taking HLNatural Supplement

  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

  At the onset of cold symptoms until resolution of cold symptoms

• Required Behavior

  During the duration of the cold symptoms

• Outcome all adverse events while taking HLNatural Supplement

  Throughout the study

• Outcome of natural behavior of the participants while taking in the clinical trial

  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

Study Arms (1)

HLNatural Immune Cohort

OTHER

Observational one arm virtual study of HLNatural Immune supplement

Dietary Supplement: HLNatural Immune

Interventions

HLNatural Immune DIETARY_SUPPLEMENT

Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water

HLNatural Immune Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawthorne Effect Inc.: lead
• HLNatural, Inc.: collaborator

Study Sites (1)

Hawthorne Effect, Inc.

Lafayette, California, 94549, United States

Location

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MeSH Terms

Conditions

Immune System Diseases

Study Officials

• Soynoa Rafatajah, MD

  Hawthorne Effect Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 25, 2019
• Study Start: October 16, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)