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

NCT04764552 | Completed

• 1 other identifier: PRO-FY2021-94
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Joint Pain

Keywords

hip; knee; topical

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Yeahhh Baby Ointment

EXPERIMENTAL

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

Dietary Supplement: Yeahhh Baby Ointment

Placebo Ointment

PLACEBO COMPARATOR

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

Other: Coconut oil ointment

Interventions

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.

Yeahhh Baby Ointment

Coconut oil ointment OTHER

Coconut oil ointment with a little olive oil.

Placebo Ointment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Memphis: lead
• YEAHHH! BABY LLC: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the College of Health Sciences

Model Details: double-blinded crossover

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: February 9, 2021
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)