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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. Identifier: NCT04103099
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : November 6, 2019
HLNatural, Inc.
Information provided by (Responsible Party):
Hawthorne Effect Inc.

Tracking Information
First Submitted Date September 13, 2019
First Posted Date September 25, 2019
Last Update Posted Date November 6, 2019
Actual Study Start Date October 16, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 23, 2019)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04103099 on Archive Site
Current Secondary Outcome Measures
 (submitted: September 23, 2019)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Impact of HLNatural Immune Supplement on Colds
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
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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will consist of at least 200 participants who have completed the self-enrollment form and who meet the inclusion-exclusion criterion. The participants will otherwise be in good health.
Condition Immune System Diseases
Intervention Dietary Supplement: HLNatural Immune
Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water
Study Groups/Cohorts Single (virtual) Arm
Observational one arm virtual study of HLNatural Immune supplement
Intervention: Dietary Supplement: HLNatural Immune
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 23, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Jerome Tonog, MD 929-410-9866
Contact: Aisling Conneally
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT04103099
Other Study ID Numbers Pro00037635
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hawthorne Effect Inc.
Study Sponsor Hawthorne Effect Inc.
Collaborators HLNatural, Inc.
Principal Investigator: Soynoa Rafatajah, MD Hawthorne Effect Inc.
PRS Account Hawthorne Effect Inc.
Verification Date October 2019