Headache Clinical Trial
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
Verified date | November 2021 |
Source | Hawthorne Effect Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 117 |
Est. completion date | September 16, 2020 |
Est. primary completion date | August 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
United States | Hawthorne Effect, Inc. | Lafayette | California |
Lead Sponsor | Collaborator |
---|---|
Hawthorne Effect Inc. | HLNatural, Inc. |
United States,
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* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Evaluation of the Impact of HLNatural Tension Relief Product for Adults who Suffer from Mild to Moderate Tension Headaches | 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 | Understanding If HLNatural impacts the Intensity of Tension Headaches. Headaches.another intervention | 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 | |
Secondary | Outcome of all Adverse Events while consuming HLNatural Suppliement | 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. | |
Secondary | Outcome of Subjects Natural Behavior During the Clinical Trial | 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. |
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