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

Sponsor

ESM Technologies, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00750854

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Fibromyalgia	Dietary Supplement: NEM Formulation X Dietary Supplement: NEM Formulation Y	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Double Arm Study to Evaluate the Effectiveness of NEM Compositions for the Treatment of Joint and Connective Tissue Pain

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NEM Treatment 1 NEM Formulation X (#0802), 500 mg, once daily, orally	Dietary Supplement: NEM Formulation X see Treatment Arms Other Names: Natural Eggshell Membrane
Experimental: NEM Treatment 2 NEM Formulation Y (#0505), 500 mg, once daily, orally	Dietary Supplement: NEM Formulation Y see Treatment Arms Other Names: Natural Eggshell Membrane

Arm

Intervention/Treatment

Experimental: NEM Treatment 1

NEM Formulation X (#0802), 500 mg, once daily, orally

Dietary Supplement: NEM Formulation X

see Treatment Arms

Other Names:

Natural Eggshell Membrane

Experimental: NEM Treatment 2

NEM Formulation Y (#0505), 500 mg, once daily, orally

Dietary Supplement: NEM Formulation Y

see Treatment Arms

Other Names:

Natural Eggshell Membrane

Outcome Measures

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. [7 & 30 days]

Secondary Outcome Measures

A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. [7 & 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.