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

Effect of Yeahhh Baby! Ointment on Efficacy to Relieve Joint Pain in Men and Women With Hip and/or Knee Pain

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).

Study Overview

• Status: Completed
• Conditions: Joint Pain
• Intervention / Treatment: Dietary supplement: Yeahhh Baby Ointment; Other: Coconut oil ointment

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • Center for Nutraceutical and Dietary Supplement Reseach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint pain visual analog scale	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)	days 1-14
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	days 1-14
Blood pressure	Resting blood pressure will be measured.	First 1 day
Blood pressure	Resting blood pressure will be measured.	15th day
Heart Rate	Resting heart rate will be measured.	First 1 day
Heart Rate	Resting heart rate will be measured.	15th day

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: YEAHHH! BABY LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): June 7, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: knee; topical; hip
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: PRO-FY2021-94

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No