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HLNatural Tension Supplement

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091555
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
HLNatural, Inc.
Information provided by (Responsible Party):
Hawthorne Effect Inc.

Brief Summary:
The primary hypothesis of the present study is that supplementation with the Tension Relief test product will reduce the severity of symptoms of a tension headache.

Condition or disease Intervention/treatment
Tension Headache Dietary Supplement: HLNatural Tension

Detailed Description:
Patients will begin taking the capsules at the onset of headache symptoms. Onset is defined as the point in time the participant feels that it is necessary to take the test product for relief of symptoms. When the participant decides to take the test product, they will report symptoms in the headache diary prior to taking the product and rate their symptoms on a 10-point Mankoski scale. After consuming the product, the participant will complete a Mankoski scale at 15 minutes, 30 minutes and 1 hour after taking the product. If needed the participant will be allowed to take alternative medication (alternative treatment) after an hour after taking the product. If alternative medication is taken, the participant will record this in their headache diary.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Impact of the HL Natural, Inc. Tension Relief Product on the Reduction of Symptoms in Adults Who Suffer From Mild to Moderate Tension Headaches
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : August 16, 2020
Estimated Study Completion Date : September 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache


Intervention Details:
  • Dietary Supplement: HLNatural Tension
    Understand the impact of the supplement on Tension Headaches


Primary Outcome Measures :
  1. The Evaluation of the Impact of HLNatural Tension Relief Product for Adults who Suffer from Mild to Moderate Tension Headaches [ Time Frame: After taking the test product, the participant will complete a Mankoski pain scale at 15 minutes after the start of the event, 30 minutes after the start of the event, and 1 hour after the start of the event. ]
    Those subjects who meet the inclusion/exclusion criteria will be invited to be part of the study. The subject will sign consent and complete the required surgery and questionnaires before taking the test product. • At the onset of the headache, the participant will start a Headache Diary and complete a 10-point Mankoski pain scale. • After completing the surveys, the participant will take test product. The participant will take 2 capsules with 6-8 oz. of water per headache episode. With a max of 6 pills per day.


Secondary Outcome Measures :
  1. Understanding If HLNatural impacts the Intensity of Tension Headaches. Headaches.another intervention [ Time Frame: Stubjects will be evaluated for up to 60 days or 3 episodes of a headache ]
    A diary will be kept of the intensity and need for other intervention during each episode.

  2. Outcome of all Adverse Events while consuming HLNatural Suppliement [ Time Frame: All adverse events will be captured throughout the 60 days or after 3 episodes of headaches or until the subject exits the trial. ]
    Throughout the study the subject will capture any adverse events that have occurred. All events will recorded in the subject's diary.

  3. Outcome of Subjects Natural Behavior During the Clinical Trial [ Time Frame: 10-point Mankoski Scale and Headache Diary will be at the start of the headache, 15 minutes after start of the event, 30 minutes after start of event and 60 minutes after the start of the event. The activity will be repeated for up to 3 events. ]
    Before the test product is taken the subject will complete a screening, demographic and baseline survey. At the end of the survey the researchers will use what is in the literature to help establish normal behavior. Upon completion of the study the participant will complete an exit study. The surveys and questionnaires will be used to establish normal behavior of the subject.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of at least 200 adult patients who suffer from symptoms of tension headaches and who have completed the self-enrollment form and who meet the inclusion-exclusion criterion. The participants will otherwise be in good health
Criteria

Inclusion Criteria:

Adult candidates who are in overall good health and who suffer from mild to moderate tension headaches.

Participants will be deemed to be in good health if they do not report any of the existing medical conditions asked about in the screening questionnaire.

Exclusion Criteria:

  • Those who have been diagnosed with migraine headaches.
  • Those who score between 36-49 or 60-78 on screening questionnaire.
  • Is < 18 years of age
  • Those who have been diagnosed with fibromyalgia.
  • Women that are pregnant or breastfeeding.
  • Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion.
  • Routine recreational drug use such as marijuana.
  • Chronic renal disease
  • Chronic liver disease
  • Allergy to any of the following: Aspirin or any other product including Salicylates, Boswellia, Feverfew, Skullcap, White Willow Bark, Rice Hull, or Vegetable Cellulose.
  • Unable to swallow pills.
  • Unwilling to try test product for relief of pain and tension headache symptoms.
  • Participants who are currently taking any anticoagulation medications daily. (Aspirin, Warfarin, Heparin etc.)

Information from the National Library of Medicine

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): NCT04091555


Locations
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United States, California
Hawthorne Effect, Inc.
Lafayette, California, United States, 94549
Sponsors and Collaborators
Hawthorne Effect Inc.
HLNatural, Inc.
Investigators
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Principal Investigator: Soyona Rafatjah, MD Hawthorne Effect Inc.
Publications:
1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/
5. Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Cham: Springer.
7. Kubala, J., MS, RD. (2019, April 30). Skullcap: Benefits, Side Effects, and Dosage. Retrieved from https://www.healthline.com/nutrition/skullcap
11. Taylor, F. R. (2018, November 17). Tension-type headache in adults: Pathophysiology, clinical features, and diagnosis. Retrieved from https://www.uptodate.com/contents/tension-type-headache-in-adults-pathophysiology-clinical-features-and-diagnosis
12. The R Project for Statistical Computing. (n.d.). Retrieved from https://www.R-project.org/.
13. Vitamin C. (2017, October 18). Retrieved from https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932
14. Willow Bark Uses, Benefits & Dosage. (n.d.). Retrieved from https://www.drugs.com/npp/willow-bark.html
15. Wu, B. (n.d.). Magnesium glycinate: Uses, benefits, and side effects (A. Carter PharmD, Ed.). Retrieved from https://www.medicalnewstoday.com/articles/315372.php
25. Skullcap monograph. Engles, G. Herbalgram. The American Botanical Council. Issue 83, pg 1-2
29. Palevitch D, Earon G, Carasso R. Feverfew (tanacetum parthenium) as a prophylactic treatment for migraine- a double-blind, placebo-controlled study. Phytotherapy Res 1997;11:508-11.

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Responsible Party: Hawthorne Effect Inc.
ClinicalTrials.gov Identifier: NCT04091555    
Other Study ID Numbers: Pro00037556
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
Signs and Symptoms