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临床试验/NCT04764552
NCT04764552已完成不适用

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

University of Memphis1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年2月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Joint pain visual analog scale

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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)

研究组 & 干预措施

Yeahhh Baby Ointment

Experimental

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

干预措施: Yeahhh Baby Ointment (Dietary Supplement)

Placebo Ointment

Placebo Comparator

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

干预措施: Coconut oil ointment (Other)

结局指标

主要结局

Joint pain visual analog scale

时间窗: 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)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

时间窗: 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.

Blood pressure

时间窗: 15th day

Resting blood pressure will be measured.

Heart Rate

时间窗: 15th day

Resting heart rate will be measured.

Blood pressure

时间窗: First 1 day

Resting blood pressure will be measured.

Heart Rate

时间窗: First 1 day

Resting heart rate will be measured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Bloomer

Dean of the College of Health Sciences

University of Memphis

研究点 (1)

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