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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750854
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
ESM Technologies, LLC

Tracking Information
First Submitted Date  ICMJE September 10, 2008
First Posted Date  ICMJE September 11, 2008
Last Update Posted Date February 15, 2016
Study Start Date  ICMJE November 2003
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2008)
A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. [ Time Frame: 7 & 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy & Safety Study of Natural Eggshell Membrane (NEM) for the Treatment of Joint & Connective Tissue Disorders
Official Title  ICMJE A Double Arm Study to Evaluate the Effectiveness of NEM Compositions for the Treatment of Joint and Connective Tissue Pain
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Osteoarthritis
  • Fibromyalgia
Intervention  ICMJE
  • Dietary Supplement: NEM Formulation X
    see Treatment Arms
    Other Name: Natural Eggshell Membrane
  • Dietary Supplement: NEM Formulation Y
    see Treatment Arms
    Other Name: Natural Eggshell Membrane
Study Arms  ICMJE
  • Experimental: NEM Treatment 1
    NEM Formulation X (#0802), 500 mg, once daily, orally
    Intervention: Dietary Supplement: NEM Formulation X
  • Experimental: NEM Treatment 2
    NEM Formulation Y (#0505), 500 mg, once daily, orally
    Intervention: Dietary Supplement: NEM Formulation Y
Publications * Ruff KJ, DeVore DP, Leu MD, Robinson MA. Eggshell membrane: a possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies. Clin Interv Aging. 2009;4:235-40. Epub 2009 Jun 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2009)
28
Original Actual Enrollment  ICMJE
 (submitted: September 10, 2008)
26
Actual Study Completion Date  ICMJE April 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00750854
Other Study ID Numbers  ICMJE CLN# C0104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ESM Technologies, LLC
Study Sponsor  ICMJE ESM Technologies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael D Leu, D.Ph., N.D.
Study Director: Kevin J Ruff, Ph.D., MBA ESM Technologies, LLC
PRS Account ESM Technologies, LLC
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP