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

NCT04091555 | Completed

• 1 other identifier: Pro00037556
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension; Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

• Outcome of all Adverse Events while consuming HLNatural Suppliement

  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

  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.

Study Arms (1)

Adult patients who suffer from symptoms of tension headaches

OTHER

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

Dietary Supplement: HLNatural Tension

Interventions

HLNatural Tension DIETARY_SUPPLEMENT

Understand the impact of the supplement on Tension Headaches

Adult patients who suffer from symptoms of tension headaches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hawthorne Effect Inc.: lead
• HLNatural, Inc.: collaborator

Study Sites (1)

Hawthorne Effect, Inc.

Lafayette, California, 94549, United States

Location

Related Publications (29)

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

  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.

  PMID: 18815018 BACKGROUND

• 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.

  PMID: 21631494 BACKGROUND

• 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.

  PMID: 30785242 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 12622457 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29228442 BACKGROUND

• 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.

  PMID: 22096324 BACKGROUND

• 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.

  PMID: 25298573 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 9459472 BACKGROUND

• 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.

  PMID: 18339350 BACKGROUND

• 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.

  PMID: 24530196 BACKGROUND

• 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.

  PMID: 30838706 BACKGROUND

• 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.

  PMID: 17704985 BACKGROUND

• 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.

  PMID: 15070163 BACKGROUND

• 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.

  PMID: 10936472 BACKGROUND

• 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.

  PMID: 26630428 BACKGROUND

• 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.

  PMID: 25536022 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 23878109 BACKGROUND

• 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.

  PMID: 3929876 BACKGROUND

• 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.

  PMID: 2899663 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Soyona Rafatjah, MD

  Hawthorne Effect Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: October 16, 2019
• Primary Completion: August 16, 2020
• Study Completion: September 16, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)