Impact of HLNatural Immune Supplement on Colds

Immune System Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103099
• Other study ID #: Pro00037635
• Status: Completed
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: August 15, 2020

Study information

• Verified date: November 2021
• Source: Hawthorne Effect Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune System Diseases

Intervention

Dietary Supplement:
• HLNatural Immune
Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water

Locations

Country	Name	City	State
United States	Hawthorne Effect, Inc.	Lafayette	California

Sponsors (2)

Lead Sponsor	Collaborator
Hawthorne Effect Inc.	HLNatural, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The diary will be completed daily during the duration of the the subject's cold.
Secondary	Outcome of the duration of the cold symptoms while taking HLNatural Supplement	The length of time that the subject's cold will be recorded	At the onset of cold symptoms until resolution of cold symptoms
Secondary	Required Behavior	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
Secondary	Outcome all adverse events while taking HLNatural Supplement	All adverse events which are collected throughout the subjects participation will be recorded.	Throughout the study
Secondary	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	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