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

Primary Purpose

Joint Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yeahhh Baby Ointment
Coconut oil ointment
Sponsored by
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Joint Pain focused on measuring hip, knee, topical

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Center for Nutraceutical and Dietary Supplement Reseach

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yeahhh Baby Ointment

Placebo Ointment

Arm Description

Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms.

Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms.

Outcomes

Primary Outcome Measures

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)
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.
Blood pressure
Resting blood pressure will be measured.
Blood pressure
Resting blood pressure will be measured.
Heart Rate
Resting heart rate will be measured.
Heart Rate
Resting heart rate will be measured.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2021
Last Updated
December 8, 2021
Sponsor
University of Memphis
Collaborators
YEAHHH! BABY LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04764552
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Memphis
Collaborators
YEAHHH! BABY LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Pain
Keywords
hip, knee, topical

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
double-blinded crossover
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yeahhh Baby Ointment
Arm Type
Experimental
Arm Description
Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms.
Arm Title
Placebo Ointment
Arm Type
Placebo Comparator
Arm Description
Ointment will be applied per instructions twice daily during treatment with a two week washout period between arms.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yeahhh Baby Ointment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Coconut oil ointment
Intervention Description
Coconut oil ointment with a little olive oil.
Primary Outcome Measure Information:
Title
Joint pain visual analog scale
Description
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)
Time Frame
days 1-14
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
days 1-14
Title
Blood pressure
Description
Resting blood pressure will be measured.
Time Frame
First 1 day
Title
Blood pressure
Description
Resting blood pressure will be measured.
Time Frame
15th day
Title
Heart Rate
Description
Resting heart rate will be measured.
Time Frame
First 1 day
Title
Heart Rate
Description
Resting heart rate will be measured.
Time Frame
15th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bloomer, PhD
Organizational Affiliation
University of Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Nutraceutical and Dietary Supplement Reseach
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38152
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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