Efficacy & Safety Study of Natural Eggshell Membrane (NEM) for the Treatment of Joint & Connective Tissue Disorders
The purpose of this study was to evaluate the use of the dietary supplement Natural Eggshell Membrane (NEM) for the treatment of joint and connective tissue discomfort, pain, and flexibility.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Single Arm Pilot Study to Evaluate the Effectiveness of Eggshell Membrane Compositions for the Treatment of Pain Associated With Connective Tissue and Joints|
- The primary outcome measure of this study was to evaluate the mean effectiveness of NEM® in relieving general pain associated with moderate joint & connective tissue disorders. [ Time Frame: 7 & 30 days ] [ Designated as safety issue: No ]
- Additional outcome measures were to evaluate flexibility [ Time Frame: 7 & 30 days ] [ Designated as safety issue: No ]
- Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. [ Time Frame: 7 & 30 days ] [ Designated as safety issue: Yes ]
- To evaluate pain associated with the range of motion (ROM) evaluation. [ Time Frame: 7 & 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||January 2004|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
Experimental: NEM Treatment
Treatment for 30 days.
Dietary Supplement: Natural Eggshell Membrane
500 mg, once daily, orally
It is estimated that 140 million adults in the U.S. suffer from some form of joint or connective tissue (JCT) disorder (i.e. arthritis, lupus, gout, fibromyalgia, neck or back pain, etc.). As the population ages, this estimate is expected to grow rapidly. Traditional treatments for most of these disorders attempt to address only the symptoms (pain, inflammation, and discomfort) associated with the diseases. This usually involves the use of analgesics (i.e. acetaminophen, oxycodone, propoxyphene) or non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, diclofenac, celecoxib), alone or in combination. Most of these treatments have shown limited effectiveness in randomized controlled clinical trials (RCTs) or are known to have significant and sometimes severe side effects. To avoid the cardiac risks, gastrointestinal issues , and dependency issues associated with traditional JCT treatments (particularly with long-term use), many patients have turned to complementary and alternative medicines (CAMs) such as dietary supplements.
Glucosamine, chondroitin, and methylsulfonylmethane (MSM) alone and in combination, are widely marketed as dietary supplements to treat joint pain due to osteoarthritis (OA). Other vitamins, minerals, and botanicals such as kava, pine bark extract, capsicum, boswellia root extract, turmeric/curcumin, etc. are also marketed for various JCT pain maladies. We present here the use of eggshell membrane as a possible new natural therapeutic for JCT disorders. A single center, open label human clinical study was conducted to evaluate the efficacy and safety of NEM® as a treatment for pain and inflexibility associated with joint and connective tissue disorders. Subjects were to take NEM, 500mg, once daily for 30 days. Subjects were then evaluated for pain and range of motion.
|United States, Missouri|
|Robinson Family Clinic|
|Carthage, Missouri, United States, 64836|
|Study Director:||Kevin J Ruff, Ph.D., MBA||ESM Technologies, LLC|
|Principal Investigator:||Mark A Robinson, D.C.|