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

Primary Purpose

Tension, Headache

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HLNatural Tension

About this trial

This is an interventional other trial for Tension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

Hawthorne Effect, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adult patients who suffer from symptoms of tension headaches

Arm Description

Patients will begin taking the capsules at the onset of headache symptoms.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04091555

First Posted

September 13, 2019

Last Updated

November 5, 2021

Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04091555

Brief Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 16, 2019 (Actual)

Primary Completion Date

August 16, 2020 (Actual)

Study Completion Date

September 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hawthorne Effect Inc.

Collaborators

HLNatural, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tension, Headache

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adult patients who suffer from symptoms of tension headaches

Arm Type

Other

Arm Description

Patients will begin taking the capsules at the onset of headache symptoms.

Intervention Type

Dietary Supplement

Intervention Name(s)

HLNatural Tension

Intervention Description

Understand the impact of the supplement on Tension Headaches

Primary Outcome Measure Information:

Title

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

Description

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.

Secondary Outcome Measure Information:

Title

Understanding If HLNatural impacts the Intensity of Tension Headaches. Headaches.another intervention

Description

A diary will be kept of the intensity and need for other intervention during each episode.

Time Frame

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

Title

Outcome of all Adverse Events while consuming HLNatural Suppliement

Description

Throughout the study the subject will capture any adverse events that have occurred. All events will recorded in the subject's diary.

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.

Title

Outcome of Subjects Natural Behavior During the Clinical Trial

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soyona Rafatjah, MD

Organizational Affiliation

Hawthorne Effect Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hawthorne Effect, Inc.

City

Lafayette

State/Province

California

ZIP/Postal Code

94549

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

1. 15 Pain Scales (And How to Find The Best Pain Scale For You). (2018, January 05). Retrieved from https://paindoctor.com/pain-scales/

Results Reference

background

PubMed Identifier

18815018

Citation

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.

Results Reference

background

PubMed Identifier

21631494

Citation

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.

Results Reference

background

PubMed Identifier

30785242

Citation

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.

Results Reference

background

Citation

5. Friedman, L. M., Furberg, C., DeMets, D. L., Reboussin, D., & Granger, C. B. (2015). Fundamentals of clinical trials. Cham: Springer.

Results Reference

background

PubMed Identifier

12622457

Citation

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.

Results Reference

background

Citation

7. Kubala, J., MS, RD. (2019, April 30). Skullcap: Benefits, Side Effects, and Dosage. Retrieved from https://www.healthline.com/nutrition/skullcap

Results Reference

background

PubMed Identifier

29228442

Citation

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.

Results Reference

background

PubMed Identifier

22096324

Citation

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.

Results Reference

background

PubMed Identifier

25298573

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

12. The R Project for Statistical Computing. (n.d.). Retrieved from https://www.R-project.org/.

Results Reference

background

Citation

13. Vitamin C. (2017, October 18). Retrieved from https://www.mayoclinic.org/drugs-supplements-vitamin-c/art-20363932

Results Reference

background

Citation

14. Willow Bark Uses, Benefits & Dosage. (n.d.). Retrieved from https://www.drugs.com/npp/willow-bark.html

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

9459472

Citation

Schwartz BS, Stewart WF, Simon D, Lipton RB. Epidemiology of tension-type headache. JAMA. 1998 Feb 4;279(5):381-3. doi: 10.1001/jama.279.5.381.

Results Reference

background

PubMed Identifier

18339350

Citation

Jensen R, Stovner LJ. Epidemiology and comorbidity of headache. Lancet Neurol. 2008 Apr;7(4):354-61. doi: 10.1016/S1474-4422(08)70062-0.

Results Reference

background

PubMed Identifier

24530196

Citation

Douglas ME, Randleman ML, DeLane AM, Palmer GA. Determining pain scale preference in a veteran population experiencing chronic pain. Pain Manag Nurs. 2014 Sep;15(3):625-31. doi: 10.1016/j.pmn.2013.06.003. Epub 2014 Feb 14.

Results Reference

background

PubMed Identifier

30838706

Citation

Majeed M, Majeed S, Narayanan NK, Nagabhushanam K. A pilot, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee. Phytother Res. 2019 May;33(5):1457-1468. doi: 10.1002/ptr.6338. Epub 2019 Mar 6.

Results Reference

background

PubMed Identifier

17704985

Citation

Nahrstedt A, Schmidt M, Jaggi R, Metz J, Khayyal MT. Willow bark extract: the contribution of polyphenols to the overall effect. Wien Med Wochenschr. 2007;157(13-14):348-51. doi: 10.1007/s10354-007-0437-3.

Results Reference

background

PubMed Identifier

15070163

Citation

Fiebich BL, Chrubasik S. Effects of an ethanolic salix extract on the release of selected inflammatory mediators in vitro. Phytomedicine. 2004 Feb;11(2-3):135-8. doi: 10.1078/0944-7113-00338.

Results Reference

background

PubMed Identifier

10936472

Citation

Chrubasik S, Eisenberg E, Balan E, Weinberger T, Luzzati R, Conradt C. Treatment of low back pain exacerbations with willow bark extract: a randomized double-blind study. Am J Med. 2000 Jul;109(1):9-14. doi: 10.1016/s0002-9343(00)00442-3.

Results Reference

background

PubMed Identifier

26630428

Citation

Gagnier JJ, Oltean H, van Tulder MW, Berman BM, Bombardier C, Robbins CB. Herbal Medicine for Low Back Pain: A Cochrane Review. Spine (Phila Pa 1976). 2016 Jan;41(2):116-33. doi: 10.1097/BRS.0000000000001310.

Results Reference

background

PubMed Identifier

25536022

Citation

Oltean H, Robbins C, van Tulder MW, Berman BM, Bombardier C, Gagnier JJ. Herbal medicine for low-back pain. Cochrane Database Syst Rev. 2014 Dec 23;2014(12):CD004504. doi: 10.1002/14651858.CD004504.pub4.

Results Reference

background

Citation

25. Skullcap monograph. Engles, G. Herbalgram. The American Botanical Council. Issue 83, pg 1-2

Results Reference

background

PubMed Identifier

23878109

Citation

Brock C, Whitehouse J, Tewfik I, Towell T. American Skullcap (Scutellaria lateriflora): a randomised, double-blind placebo-controlled crossover study of its effects on mood in healthy volunteers. Phytother Res. 2014 May;28(5):692-8. doi: 10.1002/ptr.5044. Epub 2013 Jul 22.

Results Reference

background

PubMed Identifier

3929876

Citation

Johnson ES, Kadam NP, Hylands DM, Hylands PJ. Efficacy of feverfew as prophylactic treatment of migraine. Br Med J (Clin Res Ed). 1985 Aug 31;291(6495):569-73. doi: 10.1136/bmj.291.6495.569.

Results Reference

background

PubMed Identifier

2899663

Citation

Murphy JJ, Heptinstall S, Mitchell JR. Randomised double-blind placebo-controlled trial of feverfew in migraine prevention. Lancet. 1988 Jul 23;2(8604):189-92. doi: 10.1016/s0140-6736(88)92289-1.

Results Reference

background

Citation

29. Palevitch D, Earon G, Carasso R. Feverfew (tanacetum parthenium) as a prophylactic treatment for migraine- a double-blind, placebo-controlled study. Phytotherapy Res 1997;11:508-11.

Results Reference

background

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

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