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

This study has been completed.
Sponsor:
Information provided by:
ESM Technologies, LLC
ClinicalTrials.gov Identifier:
NCT00750230
First received: September 8, 2008
Last updated: June 30, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Osteoarthritis
Fibromyalgia
Dietary Supplement: Natural Eggshell Membrane

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by ESM Technologies, LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: October 2003
Study Completion Date: January 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEM Treatment
Treatment for 30 days.
Dietary Supplement: Natural Eggshell Membrane
500 mg, once daily, orally

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750230

Locations
United States, Missouri
Robinson Family Clinic
Carthage, Missouri, United States, 64836
Sponsors and Collaborators
ESM Technologies, LLC
Investigators
Study Director: Kevin J Ruff, Ph.D., MBA ESM Technologies, LLC
Principal Investigator: Mark A Robinson, D.C.
  More Information

Additional Information:
Publications:
Responsible Party: Kevin Ruff - Director of Scientific & Regulatory Affairs, ESM Technologies, LLC
ClinicalTrials.gov Identifier: NCT00750230     History of Changes
Other Study ID Numbers: CLN# A0803
Study First Received: September 8, 2008
Last Updated: June 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by ESM Technologies, LLC:
arthritis
osteoarthritis
fibromyalgia
connective tissue disorder

Additional relevant MeSH terms:
Connective Tissue Diseases
Fibromyalgia
Myofascial Pain Syndromes
Osteoarthritis
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Arthritis
Joint Diseases

ClinicalTrials.gov processed this record on April 17, 2014