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

Hawthorne Effect

Status

Completed

Conditions

Tension

Headache

Treatments

Dietary Supplement: HLNatural Tension

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04091555

Pro00037556

Details and patient eligibility

About

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.

Full 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.

Enrollment

117 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)