Clinical trial NCT04764552: Yeahhh Baby! Ointment on Hip and/or Knee Pain in Men and Women
Official title: Effect of Yeahhh Baby! Ointment on Efficacy to Relieve Joint Pain in Men and Women With Hip and/or Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Keywords: hip
knee
topical
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: YEAHHH! BABY LLC
First posted: 2021-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double-blinded crossover
Primary purpose: BASIC_SCIENCE

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).

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).

Eligibility 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)

Primary outcomes:
measure: Joint pain visual analog scale
timeFrame: days 1-14
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: days 1-14
measure: Blood pressure
timeFrame: First 1 day
measure: Blood pressure
timeFrame: 15th day
measure: Heart Rate
timeFrame: First 1 day
measure: Heart Rate
timeFrame: 15th day
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Reseach
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: