CClinicalTrials.gg
CompletedNCT00750230Updated Sep 7, 2023

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

An interventional study of NEM in Osteoarthritis and Fibromyalgia, sponsored by ESM Technologies, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by ESM Technologies, LLC · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis
  • Fibromyalgia

Keywords

  • arthritis
  • osteoarthritis
  • fibromyalgia
  • connective tissue disorder
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 11 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

ESM Technologies, LLC is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    NEM Treatment

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

    Dietary Supplement: NEM

Interventions

  • Dietary supplementNEM

    see Treatment Arm

    Also known as: Natural Eggshell Membrane

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Additional outcome measures were to evaluate flexibility

    Time frame: 7 & 30 days

  2. Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.

    Time frame: 7 & 30 days

  3. To evaluate pain associated with the range of motion (ROM) evaluation.

    Time frame: 7 & 30 days

07

Study locations

1 site
  • Robinson Family Clinic
    Carthage, Missouri 64836, United States
08

References and documents

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. PubMed 19554094 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00750230
Lead sponsor
ESM Technologies, LLC
Responsible party
Sponsor
First posted
Sep 10, 2008
Start date
Oct 2003
Primary completion
Dec 2003
Completion
Jan 2004
Last update
Sep 7, 2023

Study contacts

Kevin J Ruff, Ph.D., MBA
study director · ESM Technologies, LLC
Mark A Robinson, D.C.
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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