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

Primary Purpose

Osteoarthritis, Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEM
Sponsored by
ESM Technologies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring arthritis, osteoarthritis, fibromyalgia, connective tissue disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Robinson Family Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEM Treatment

Arm Description

NEM, 500 mg, once daily, orally for 30 days.

Outcomes

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.

Secondary Outcome Measures

Additional outcome measures were to evaluate flexibility
Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
To evaluate pain associated with the range of motion (ROM) evaluation.

Full Information

First Posted
September 8, 2008
Last Updated
September 5, 2023
Sponsor
ESM Technologies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00750230
Brief Title
Pilot Study of the Efficacy & Safety of Natural Eggshell Membrane (NEM) for Joint & Connective Tissue Disorders
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ESM Technologies, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Fibromyalgia
Keywords
arthritis, osteoarthritis, fibromyalgia, connective tissue disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NEM Treatment
Arm Type
Experimental
Arm Description
NEM, 500 mg, once daily, orally for 30 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
NEM
Other Intervention Name(s)
Natural Eggshell Membrane
Intervention Description
see Treatment Arm
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Additional outcome measures were to evaluate flexibility
Time Frame
7 & 30 days
Title
Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
Time Frame
7 & 30 days
Title
To evaluate pain associated with the range of motion (ROM) evaluation.
Time Frame
7 & 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J Ruff, Ph.D., MBA
Organizational Affiliation
ESM Technologies, LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark A Robinson, D.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robinson Family Clinic
City
Carthage
State/Province
Missouri
ZIP/Postal Code
64836
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19554094
Citation
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.
Results Reference
result
Links:
URL
http://www.dovepress.com/articles.php?article_id=3142
Description
Study published in Clinical Interventions in Aging

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

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