Clinical trial NCT04091555: Evaluation of the Impact of the HL Natural, Inc. Tension Relief Product
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension
Headache
Lead sponsor: Hawthorne Effect Inc.
Sponsor class: OTHER
Collaborators: name: HLNatural, Inc.
First posted: 2019-09-17
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility 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.)

Primary outcomes:
measure: The Evaluation of the Impact of HLNatural Tension Relief Product for Adults who Suffer from Mild to Moderate Tension Headaches
timeFrame: 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 outcomes:
measure: Understanding If HLNatural impacts the Intensity of Tension Headaches. Headaches.another intervention
timeFrame: Stubjects will be evaluated for up to 60 days or 3 episodes of a headache
measure: Outcome of all Adverse Events while consuming HLNatural Suppliement
timeFrame: All adverse events will be captured throughout the 60 days or after 3 episodes of headaches or until the subject exits the trial.
measure: Outcome of Subjects Natural Behavior During the Clinical Trial
timeFrame: 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.
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Hawthorne Effect, Inc.
state: California
Study officials:
affiliation: Hawthorne Effect Inc.
name: Soyona Rafatjah, MD
role: PRINCIPAL_INVESTIGATOR
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