Status:
COMPLETED
Evaluation of the Impact of the HL Natural, Inc. Tension Relief Product
Lead Sponsor:
Hawthorne Effect Inc.
Collaborating Sponsors:
HLNatural, Inc.
Conditions:
Tension
Headache
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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 sympt...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2020
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04091555
Start Date
October 16 2019
End Date
September 16 2020
Last Update
November 15 2021
Active Locations (1)
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1
Hawthorne Effect, Inc.
Lafayette, California, United States, 94549