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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
200
Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water
Hawthorne Effect, Inc.
Lafayette, California, United States
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).
Time frame: At the onset of cold symptoms the symptoms will be measured for 18 days or sooner if the symptoms resolve.
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.
Time frame: 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
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
Required Behavior
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
Outcome all adverse events while taking HLNatural Supplement
All adverse events which are collected throughout the subjects participation will be recorded.
Time frame: Throughout the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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