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

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

Tracking Information

• First Submitted Date: September 10, 2008
• First Posted Date: September 11, 2008
• Last Update Posted Date: February 15, 2016
• Study Start Date: November 2003
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy & Safety Study of Natural Eggshell Membrane (NEM) for the Treatment of Joint & Connective Tissue Disorders
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Osteoarthritis
• Fibromyalgia

Intervention

• 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

• 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. doi: 10.2147/cia.s5797. Epub 2009 Jun 9.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 20, 2009): 28
• Original Actual Enrollment (submitted: September 10, 2008): 26
• Actual Study Completion Date: April 2004
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00750854
• Other Study ID Numbers: CLN# C0104
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ESM Technologies, LLC
• Original Responsible Party: Kevin Ruff - Technical Director, ESM Technologies, LLC.
• Current Study Sponsor: ESM Technologies, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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