Efficacy & Safety Study of Natural Eggshell Membrane (NEM) for the Treatment of Joint & Connective Tissue Disorders
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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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Fibromyalgia |
Dietary Supplement: Natural Eggshell Membrane |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Double Arm Study to Evaluate the Effectiveness of Eggshell Membrane Compositions for the Treatment of Joint and Connective Tissue Pain |
- 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 ]
- A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. [ Time Frame: 7 & 30 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 28 |
| Study Start Date: | November 2003 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NEM Treatment 1
NEM Formulation X (#0802)
|
Dietary Supplement: Natural Eggshell Membrane
Formulation #0802, 500 mg, once daily, orally
|
|
Experimental: NEM Treatment 2
NEM Formulation Y (#0505)
|
Dietary Supplement: Natural Eggshell Membrane
Formulation #0505, 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 associated with joint and connective tissue disorders. Subjects were to take NEM, 500mg, once daily for 30 days. Subjects were then evaluated for pain.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- 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| United States, Oklahoma | |
| Leu Private Practice | |
| Jenks, Oklahoma, United States, 74037 | |
| Principal Investigator: | Michael D Leu, D.Ph., N.D. | |
| Study Director: | Kevin J Ruff, Ph.D., MBA | ESM Technologies, LLC |
More Information
Additional Information:
Publications:
| Responsible Party: | Kevin Ruff - Director of Scientific & Regulatory Affairs, ESM Technologies, LLC. |
| ClinicalTrials.gov Identifier: | NCT00750854 History of Changes |
| Other Study ID Numbers: | CLN# C0104 |
| Study First Received: | September 10, 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 June 18, 2013