Impact of HLNatural Immune Supplement on Colds

November 5, 2021 updated by: Hawthorne Effect Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lafayette, California, United States, 94549
        • Hawthorne Effect, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: HLNatural Immune Cohort
Observational one arm virtual study of HLNatural Immune supplement
Dietary supplement: HLNatural Immune
Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of freedom of cold symptoms while consuming HLNatural Supplement
Time Frame: At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of the severity of cold symptoms while taking HLNatural Supplement
Time Frame: The diary will be completed daily during the duration of the the subject's cold.

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.
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
Time Frame: At the onset of cold symptoms until resolution of cold symptoms
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
Time Frame: During the duration of the cold symptoms
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
Time Frame: Throughout the study
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

Investigators

  • Principal Investigator: Soynoa Rafatajah, MD, Hawthorne Effect Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2019

Primary Completion (ACTUAL)

August 15, 2020

Study Completion (ACTUAL)

August 15, 2020

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (ACTUAL)

September 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00037635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immune System Diseases

Clinical Trials on HLNatural Immune

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe