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Impact of HLNatural Immune Supplement on Colds

Primary Purpose

Immune System Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HLNatural Immune

About this trial

This is an interventional other trial for Immune System Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hawthorne Effect, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HLNatural Immune Cohort

Arm Description

Observational one arm virtual study of HLNatural Immune supplement

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Outcome of the duration of the cold symptoms while taking HLNatural Supplement

The length of time that the subject's cold will be recorded

Required Behavior

Subjects will be asked to avoid over the counter cold-relief medication. However pain relievers and fever reducers are allowed

Outcome all adverse events while taking HLNatural Supplement

All adverse events which are collected throughout the subjects participation will be recorded.

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

Full Information

NCT ID

NCT04103099

First Posted

September 13, 2019

Last Updated

November 5, 2021

Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04103099

Brief Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 16, 2019 (Actual)

Primary Completion Date

August 15, 2020 (Actual)

Study Completion Date

August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune System Diseases

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HLNatural Immune Cohort

Arm Type

Other

Arm Description

Observational one arm virtual study of HLNatural Immune supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

HLNatural Immune

Intervention Description

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

Primary Outcome Measure Information:

Title

Outcome of freedom of cold symptoms while consuming HLNatural Supplement

Description

Time Frame

At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve.

Secondary Outcome Measure Information:

Title

Outcome of the severity of cold symptoms while taking HLNatural Supplement

Description

Time Frame

The diary will be completed daily during the duration of the the subject's cold.

Title

Outcome of the duration of the cold symptoms while taking HLNatural Supplement

Description

The length of time that the subject's cold will be recorded

Time Frame

At the onset of cold symptoms until resolution of cold symptoms

Title

Required Behavior

Description

Subjects will be asked to avoid over the counter cold-relief medication. However pain relievers and fever reducers are allowed

Time Frame

During the duration of the cold symptoms

Title

Outcome all adverse events while taking HLNatural Supplement

Description

All adverse events which are collected throughout the subjects participation will be recorded.

Time Frame

Throughout the study

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soynoa Rafatajah, MD

Organizational Affiliation

Hawthorne Effect Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hawthorne Effect, Inc.

City

Lafayette

State/Province

California

ZIP/Postal Code

94549

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Impact of HLNatural Immune Supplement on Colds

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