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

NCT ID: NCT04764552

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-09

Study Completion Date

2021-06-07

Brief Summary

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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

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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).

Conditions

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Joint Pain

Keywords

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hip knee topical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

double-blinded crossover
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Yeahhh Baby Ointment

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

Group Type EXPERIMENTAL

Yeahhh Baby Ointment

Intervention Type DIETARY_SUPPLEMENT

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 Ointment

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

Group Type PLACEBO_COMPARATOR

Coconut oil ointment

Intervention Type OTHER

Coconut oil ointment with a little olive oil.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Coconut oil ointment

Coconut oil ointment with a little olive oil.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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YEAHHH! BABY LLC

UNKNOWN

Sponsor Role collaborator

University of Memphis

OTHER

Sponsor Role lead

Responsible Party

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Richard Bloomer

Dean of the College of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Bloomer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

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Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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PRO-FY2021-94

Identifier Type: -

Identifier Source: org_study_id