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Yeahhh Baby! Ointment on Hip and/or Knee Pain in Men and Women

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ClinicalTrials.gov Identifier: NCT04764552
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : December 29, 2021
Sponsor:
Collaborator:
YEAHHH! BABY LLC
Information provided by (Responsible Party):
Richard Bloomer, University of Memphis

Study Description
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Brief Summary:
This study will compare the impact of the Yeahhh Baby! Ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. The hypothesis is that perceived pain will be reduced when subjects use the Yeahhh Baby! Ointment. Previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (The Western Ontario and McMaster Universities Arthritis Index [WOMAC] and visual analog scale [VAS] for pain).

Condition or disease Intervention/treatment Phase
Joint Pain Dietary Supplement: Yeahhh Baby Ointment Other: Coconut oil ointment Not Applicable

Detailed Description:

Joint pain is a common ailment among adults in the United States. In 2014, an estimated 14.6 million Americans with arthritis suffered from severe joint pain. It is therefore unsurprising that many topical ointments are currently marketed for joint pain relief including Bengay®, Icy Hot®, Jointflex®, and Aspercreme®. These ointments aim to reduce pain often through a combination of analgesic ingredients include capsaicin, salicylates, menthol, camphor, and lidocaine. Bengay® products, for instance, contain one or more of menthol, camphor, salicylates, and lidocaine. Icy Hot® products contain menthol, while some also include lidocaine.

Yeahhh Baby! ointment is an herbal (botanical: plant-based) treatment for those impacted by joint pain. The product contains a variety of herbal ingredients that have been touted by some within the alternative medicine community as "healing agents." The product started selling in 2016 and is available commercially as an all-natural alternative to other commercially available products. This ointment consists primarily of coconut oil (98%), with magnesium and small amounts of herbal ingredients (tanner's bark, slippery root, sweet weed, velvet plant, walnut hulls, kidney root, green ginger, Indian pink, mad dogweed, and nigella seed) thought to reduce inflammation and to promote tissue healing.

The present study will compare the impact of the Yeahhh Baby! Ointment, as compared to a placebo, on measures of joint pain and discomfort in those who regularly experience joint pain. The hypothesis is that perceived pain will be reduced when subjects use the Yeahhh Baby! Ointment. Previous studies exploring the efficacy of topicals on joint pain relief have used a similar design and similar joint pain assessments as employed herein (The Western Ontario and McMaster Universities Arthritis Index [WOMAC] and visual analog scale [VAS] for pain).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: double-blinded crossover
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Yeahhh Baby! Ointment on Efficacy to Relieve Joint Pain in Men and Women With Hip and/or Knee Pain
Actual Study Start Date : February 9, 2021
Actual Primary Completion Date : June 7, 2021
Actual Study Completion Date : June 7, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Yeahhh Baby Ointment
Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms.
 Dietary Supplement: Yeahhh Baby Ointment
The ointment consists primarily of coconut oil (98%), with small amounts of herbal ingredients (tanner's bark, slippery root, sweet weed, velvet plant, walnut hulls, kidney root, green ginger, Indian pink, mad dogweed, and nigella seed) thought to reduce inflammation and to promote tissue healing.
Placebo Comparator: Placebo Ointment
Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms.
 Other: Coconut oil ointment
Coconut oil ointment with a little olive oil.


Outcome Measures
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Primary Outcome Measures :
  1. Joint pain visual analog scale [ Time Frame: days 1-14 ]
    A 100mm visual analog scale will be used to assess join pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree)

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: days 1-14 ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most.

  3. Blood pressure [ Time Frame: First 1 day ]
    Resting blood pressure will be measured.

  4. Blood pressure [ Time Frame: 15th day ]
    Resting blood pressure will be measured.

  5. Heart Rate [ Time Frame: First 1 day ]
    Resting heart rate will be measured.

  6. Heart Rate [ Time Frame: 15th day ]
    Resting heart rate will be measured.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30 days
  • Recreationally active (2 or more days per week)
  • Not obese (BMI < 30kg/m2)

Exclusion Criteria:

  • Tobacco users/Smokers
  • Allergic to coconut, walnuts, oak, olives
  • Currently using anti-inflammatory medicines or dietary supplements (and not willing to cease for one-month prior to participation and throughout study)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764552


Locations
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United States, Tennessee
Center for Nutraceutical and Dietary Supplement Reseach
Memphis, Tennessee, United States, 38152
Sponsors and Collaborators
University of Memphis
YEAHHH! BABY LLC
Investigators
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Principal Investigator: Richard Bloomer, PhD University of Memphis
More Information
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Responsible Party: Richard Bloomer, Dean of the College of Health Sciences, University of Memphis
ClinicalTrials.gov Identifier: NCT04764552    
Other Study ID Numbers: PRO-FY2021-94
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Bloomer, University of Memphis:
hip
knee
topical
Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations