Clinical Trials Directory

Trials / Completed

CompletedNCT00750230

Pilot Study of the Efficacy & Safety of Natural Eggshell Membrane (NEM) for Joint & Connective Tissue Disorders

A Single Arm Pilot Study to Evaluate the Effectiveness of Eggshell Membrane Compositions for the Treatment of Pain Associated With Connective Tissue and Joints

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
ESM Technologies, LLC · Industry
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNEMsee Treatment Arm

Timeline

Start date
2003-10-01
Primary completion
2003-12-01
Completion
2004-01-01
First posted
2008-09-10
Last updated
2023-09-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00750230. Inclusion in this directory is not an endorsement.