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| Name | Class |
|---|---|
| HLNatural, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients who suffer from symptoms of tension headaches | Other | Patients will begin taking the capsules at the onset of headache symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLNatural Tension | Dietary Supplement | Understand the impact of the supplement on Tension Headaches |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Outcome of all Adverse Events while consuming HLNatural Suppliement |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Soyona Rafatjah, MD | Hawthorne Effect Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawthorne Effect, Inc. | Lafayette | California | 94549 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/ | ||
| 18815018 | Background | Beer AM, Wegener T. Willow bark extract (Salicis cortex) for gonarthrosis and coxarthrosis--results of a cohort study with a control group. Phytomedicine. 2008 Nov;15(11):907-13. doi: 10.1016/j.phymed.2008.07.010. Epub 2008 Sep 23. | |
| 21631494 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 17, 2019 | Oct 14, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 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. |
| Background |
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