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

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ClinicalTrials.gov Identifier: NCT00750854
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : February 15, 2016
Information provided by (Responsible Party):
ESM Technologies, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Fibromyalgia Dietary Supplement: NEM Formulation X Dietary Supplement: NEM Formulation Y Not Applicable

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 associated with joint and connective tissue disorders. Subjects were to take NEM, 500mg, once daily for 30 days. Subjects were then evaluated for pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Double Arm Study to Evaluate the Effectiveness of NEM Compositions for the Treatment of Joint and Connective Tissue Pain
Study Start Date : November 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NEM Treatment 1
NEM Formulation X (#0802), 500 mg, once daily, orally
Dietary Supplement: NEM Formulation X
see Treatment Arms
Other Name: Natural Eggshell Membrane

Experimental: NEM Treatment 2
NEM Formulation Y (#0505), 500 mg, once daily, orally
Dietary Supplement: NEM Formulation Y
see Treatment Arms
Other Name: Natural Eggshell Membrane

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. [ Time Frame: 7 & 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients seeking relief of mild to moderate pain due to joint or connective tissue (JCT)disorders.
  • subjects must have had persistent pain associated with a JCT disorder.
  • subjects were required to suspend all current pain relief medications.
  • Subjects that were currently taking analgesic medications were eligible to participate in the studies following a 14 day washout period for NSAIDs, a 7 day washout for narcotics, and a 90 day washout for injected steroids.
  • subjects currently taking glucosamine, chondroitin sulfate or MSM were only eligible after a 3-month washout period.

Exclusion Criteria:

  • Patients were excluded if they were currently receiving remission-inducing drugs such as methotrexate or immunosuppressive medications or had received them within the past 3 months.
  • body weight 250 pounds or greater.
  • a known allergy to eggs or egg products.
  • pregnant or breastfeeding women.
  • subjects previously enrolled in a study to evaluate pain relief within the past 6 months or currently involved in any other research study involving an investigational product (drug, device, or biologic) or a new application of an approved product, within 30 days of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750854

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United States, Oklahoma
Leu Private Practice
Jenks, Oklahoma, United States, 74037
Sponsors and Collaborators
ESM Technologies, LLC
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Principal Investigator: Michael D Leu, D.Ph., N.D.
Study Director: Kevin J Ruff, Ph.D., MBA ESM Technologies, LLC
Additional Information:
Publications of Results:
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Responsible Party: ESM Technologies, LLC
ClinicalTrials.gov Identifier: NCT00750854    
Other Study ID Numbers: CLN# C0104
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ESM Technologies, LLC:
connective tissue disorder
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases