TensionNCT04091555

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

A study testing HLNatural Tension in people with Tension and Headache, run by Hawthorne Effect Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tension, Headache
What is being tested?: HLNatural Tension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 1 siteUnited States
Study dates: 16 Oct 2019to 16 Sep 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

Hawthorne Effect, Inc.
Lafayette, California, 94549

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Tension, Headache
Being tested: HLNatural Tension
Medical subject headings: Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HLNatural TensionDietary supplement
Understand the impact of the supplement on Tension Headaches

Study groups in NCT04091555
Study group	Role	What they receive
Adult patients who suffer from symptoms of tension headaches	Other	Patients will begin taking the capsules at the onset of headache symptoms. Receives: Dietary Supplement: HLNatural Tension

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (3)

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.
Measured: Stubjects will be evaluated for up to 60 days or 3 episodes of a headache
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.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 201916 Sep 2020

First posted17 Sep 2019
Study start16 Oct 2019
Primary completion16 Aug 2020
Study completion16 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for TensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04091555
Sponsor's protocol ID: Pro00037556
Status last verified: Nov 2021
First submitted: 13 Sep 2019
Last updated: 15 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/
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.
PubMed 18815018
Cady RK, Goldstein J, Nett R, Mitchell R, Beach ME, Browning R. A double-blind placebo-controlled pilot study of sublingual feverfew and ginger (LipiGesic M) in the treatment of migraine. Headache. 2011 Jul-Aug;51(7):1078-86. doi: 10.1111/j.1526-4610.2011.01910.x. Epub 2011 Jun 1.
PubMed 21631494
Ertsey C, Magyar M, Gyure T, Balogh E, Bozsik G. [Tension type headache and its treatment possibilities]. Ideggyogy Sz. 2019 Jan 30;72(1-2):13-21. doi: 10.18071/isz.72.0013. Hungarian.
PubMed 30785242
5. Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Cham: Springer.
Kimmatkar N, Thawani V, Hingorani L, Khiyani R. Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee--a randomized double blind placebo controlled trial. Phytomedicine. 2003 Jan;10(1):3-7. doi: 10.1078/094471103321648593.
PubMed 12622457
7. Kubala, J., MS, RD. (2019, April 30). Skullcap: Benefits, Side Effects, and Dosage. Retrieved from https://www.healthline.com/nutrition/skullcap
Riva A, Allegrini P, Franceschi F, Togni S, Giacomelli L, Eggenhoffner R. A novel boswellic acids delivery form (Casperome(R)) in the management of musculoskeletal disorders: a review. Eur Rev Med Pharmacol Sci. 2017 Nov;21(22):5258-5263. doi: 10.26355/eurrev_201711_13849.
PubMed 29228442
Pareek A, Suthar M, Rathore GS, Bansal V. Feverfew (Tanacetum parthenium L.): A systematic review. Pharmacogn Rev. 2011 Jan;5(9):103-10. doi: 10.4103/0973-7847.79105.
PubMed 22096324
Prabhavathi K, Chandra US, Soanker R, Rani PU. A randomized, double blind, placebo controlled, cross over study to evaluate the analgesic activity of Boswellia serrata in healthy volunteers using mechanical pain model. Indian J Pharmacol. 2014 Sep-Oct;46(5):475-9. doi: 10.4103/0253-7613.140570.
PubMed 25298573
11. Taylor, F. R. (2018, November 17). Tension-type headache in adults: Pathophysiology, clinical features, and diagnosis. Retrieved from https://www.uptodate.com/contents/tension-type-headache-in-adults-pathophysiology-clinical-features-and-diagnosis
12. The R Project for Statistical Computing. (n.d.). Retrieved from https://www.R-project.org/.
13. Vitamin C. (2017, October 18). Retrieved from https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932
14. Willow Bark Uses, Benefits & Dosage. (n.d.). Retrieved from https://www.drugs.com/npp/willow-bark.html
15. Wu, B. (n.d.). Magnesium glycinate: Uses, benefits, and side effects (A. Carter PharmD, Ed.). Retrieved from https://www.medicalnewstoday.com/articles/315372.php

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
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All Tension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04091555
Acronym / sponsor ID: Pro00037556
Conditions: Tension, Headache
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Hawthorne Effect Inc.University, hospital or other
Collaborators: HLNatural, Inc.
Study start: 16 Oct 2019 (actual)
Primary completion: 16 Aug 2020 (actual)
Study completion: 16 Sep 2020 (actual)
First posted: 17 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adult patients who suffer from symptoms of tension headaches	Other	Dietary Supplement: HLNatural TensionPatients will begin taking the capsules at the onset of headache symptoms.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HLNatural TensionUnderstand the impact of the supplement on Tension Headaches	Dietary supplement	Adult patients who suffer from symptoms of tension headaches

Primary outcome

The Evaluation of the Impact of HLNatural Tension Relief Product for Adults who Suffer from Mild to Moderate Tension Headaches
Time frame: 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.
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.

3 secondary outcomes

Understanding If HLNatural impacts the Intensity of Tension Headaches. Headaches.another intervention
Time frame: Stubjects will be evaluated for up to 60 days or 3 episodes of a headache
Outcome of all Adverse Events while consuming HLNatural Suppliement
Time frame: 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
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
Background1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/
Background: PubMed 18815018Beer 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.
Background: PubMed 21631494Cady RK, Goldstein J, Nett R, Mitchell R, Beach ME, Browning R. A double-blind placebo-controlled pilot study of sublingual feverfew and ginger (LipiGesic M) in the treatment of migraine. Headache. 2011 Jul-Aug;51(7):1078-86. doi: 10.1111/j.1526-4610.2011.01910.x. Epub 2011 Jun 1.
Background: PubMed 30785242Ertsey C, Magyar M, Gyure T, Balogh E, Bozsik G. [Tension type headache and its treatment possibilities]. Ideggyogy Sz. 2019 Jan 30;72(1-2):13-21. doi: 10.18071/isz.72.0013. Hungarian.
Background5. Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Cham: Springer.
Background: PubMed 12622457Kimmatkar N, Thawani V, Hingorani L, Khiyani R. Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee--a randomized double blind placebo controlled trial. Phytomedicine. 2003 Jan;10(1):3-7. doi: 10.1078/094471103321648593.
Background7. Kubala, J., MS, RD. (2019, April 30). Skullcap: Benefits, Side Effects, and Dosage. Retrieved from https://www.healthline.com/nutrition/skullcap
Background: PubMed 29228442Riva A, Allegrini P, Franceschi F, Togni S, Giacomelli L, Eggenhoffner R. A novel boswellic acids delivery form (Casperome(R)) in the management of musculoskeletal disorders: a review. Eur Rev Med Pharmacol Sci. 2017 Nov;21(22):5258-5263. doi: 10.26355/eurrev_201711_13849.
Background: PubMed 22096324Pareek A, Suthar M, Rathore GS, Bansal V. Feverfew (Tanacetum parthenium L.): A systematic review. Pharmacogn Rev. 2011 Jan;5(9):103-10. doi: 10.4103/0973-7847.79105.
Background: PubMed 25298573Prabhavathi K, Chandra US, Soanker R, Rani PU. A randomized, double blind, placebo controlled, cross over study to evaluate the analgesic activity of Boswellia serrata in healthy volunteers using mechanical pain model. Indian J Pharmacol. 2014 Sep-Oct;46(5):475-9. doi: 10.4103/0253-7613.140570.
Background11. Taylor, F. R. (2018, November 17). Tension-type headache in adults: Pathophysiology, clinical features, and diagnosis. Retrieved from https://www.uptodate.com/contents/tension-type-headache-in-adults-pathophysiology-clinical-features-and-diagnosis
Background12. The R Project for Statistical Computing. (n.d.). Retrieved from https://www.R-project.org/.
Individual participant dataSharing planned: No

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Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Soyona Rafatjah, MD principal investigator

Hawthorne Effect Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HLNatural Tension in people with Tension and Headache, run by Hawthorne Effect Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Evaluation of the Impact of HLNatural Tension Relief Product for Adults who Suffer from Mild to Moderate Tension Headaches (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04091555, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.