Evaluation of the Impact of the HL Natural, Inc. Tension Relief Product

November 5, 2021 updated by: Hawthorne Effect Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Lafayette, California, United States, 94549
        • Hawthorne Effect, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Adult patients who suffer from symptoms of tension headaches
Patients will begin taking the capsules at the onset of headache symptoms.
Dietary supplement: HLNatural Tension
Understand the impact of the supplement on Tension Headaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Stubjects will be evaluated for up to 60 days or 3 episodes of a headache
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.
All adverse events will be captured throughout the 60 days or after 3 episodes of headaches or until the subject exits the trial.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

Investigators

  • Principal Investigator: Soyona Rafatjah, MD, Hawthorne Effect Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2019

Primary Completion (Actual)

August 16, 2020

Study Completion (Actual)

September 16, 2020

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00037556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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