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

Joint Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764552
• Other study ID #: PRO-FY2021-94
• Status: Completed
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: June 7, 2021

Study information

• Verified date: December 2021
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthralgia
• Joint Pain

Intervention

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.

Other:
• Coconut oil ointment
Coconut oil ointment with a little olive oil.

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Reseach	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	YEAHHH! BABY LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blood pressure	Resting blood pressure will be measured.	First 1 day
Primary	Blood pressure	Resting blood pressure will be measured.	15th day
Primary	Heart Rate	Resting heart rate will be measured.	First 1 day
Primary	Heart Rate	Resting heart rate will be measured.	15th day