Clincosm LogoSign in Get a demo

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

Sponsor
Hawthorne Effect Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT04091555
Collaborator
HLNatural, Inc. (Industry)
117
Enrollment
1
Location
1
Arm
11
Actual Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Dietary Supplement: HLNatural Tension
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
117 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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 :
Oct 16, 2019
Actual Primary Completion Date :
Aug 16, 2020
Actual Study Completion Date :
Sep 16, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The Evaluation of the Impact of HLNatural Tension Relief Product for Adults who Suffer from Mild to Moderate Tension Headaches [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hawthorne Effect, Inc. Lafayette California United States 94549

Sponsors and Collaborators

  • Hawthorne Effect Inc.
  • HLNatural, Inc.

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Hawthorne Effect Inc.
ClinicalTrials.gov Identifier:
NCT04091555
Other Study ID Numbers:
  • Pro00037556
First Posted:
Sep 17, 2019
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Headache

Study Results

No Results Posted as of Nov 15, 2021