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Impact of HLNatural Immune Supplement on Colds

Sponsor
Hawthorne Effect Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT04103099
Collaborator
HLNatural, Inc. (Industry)
200
Enrollment
1
Location
1
Arm
10
Actual Duration (Months)
20
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: HLNatural Immune
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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 symptomsThe 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)
Primary Purpose:
Other
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
Actual Study Start Date :
Oct 16, 2019
Actual Primary Completion Date :
Aug 15, 2020
Actual Study Completion Date :
Aug 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Outcome of freedom of cold symptoms while consuming HLNatural Supplement [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).

Secondary Outcome Measures

  1. 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.]

    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.

  2. Outcome of the duration of the cold symptoms while taking HLNatural Supplement [At the onset of cold symptoms until resolution of cold symptoms]

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

  3. Required Behavior [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

  4. Outcome all adverse events while taking HLNatural Supplement [Throughout the study]

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

  5. 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]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hawthorne Effect, Inc. Lafayette California United States 94549

Sponsors and Collaborators

  • Hawthorne Effect Inc.
  • HLNatural, Inc.

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Hawthorne Effect Inc.
ClinicalTrials.gov Identifier:
NCT04103099
Other Study ID Numbers:
  • Pro00037635
First Posted:
Sep 25, 2019
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Immune System Diseases

Study Results

No Results Posted as of Nov 15, 2021