Impact of HLNatural Immune Supplement on Colds
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04103099|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment|
|Immune System Diseases||Dietary Supplement: HLNatural Immune|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2020|
Single (virtual) Arm
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 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).
- 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.
- 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
- 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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103099
|Contact: Jerome Tonog, MDfirstname.lastname@example.org|
|Contact: Aisling Conneallyemail@example.com|
|United States, California|
|Hawthorne Effect, Inc.||Recruiting|
|Lafayette, California, United States, 94549|
|Contact: Jerome Tonog, MD 929-410-9866 firstname.lastname@example.org|
|Principal Investigator:||Soynoa Rafatajah, MD||Hawthorne Effect Inc.|