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NCT Number: NCT04764552

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

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).

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Key information

Conditions

Joint Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, 38152, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yeahhh Baby Ointment

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.

Coconut oil ointment

Other

Coconut oil ointment with a little olive oil.

Primary outcomes

  1. Joint pain visual analog scale

    Time frame: days 1-14

    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)

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: days 1-14

    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.

  3. Blood pressure

    Time frame: First 1 day

    Resting blood pressure will be measured.

  4. Blood pressure

    Time frame: 15th day

    Resting blood pressure will be measured.

  5. Heart Rate

    Time frame: First 1 day

    Resting heart rate will be measured.

  6. Heart Rate

    Time frame: 15th day

    Resting heart rate will be measured.

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • YEAHHH! BABY LLC

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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