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Sponsored by: |
ESM Technologies, LLC |
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Information provided by: | ESM Technologies, LLC |
ClinicalTrials.gov Identifier: | NCT00750854 |
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: | Supportive Care, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double Arm Study to Evaluate the Effectiveness of Eggshell Membrane Compositions for the Treatment of Joint and Connective Tissue Pain |
Enrollment: | 26 |
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 |
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NEM Treatment 1: Experimental
NEM Formulation X (#0802)
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Dietary Supplement: Natural Eggshell Membrane
Formulation #0802, 500 mg, once daily, orally
|
NEM Treatment 2: Experimental
NEM Formulation Y (#0505)
|
Dietary Supplement: Natural Eggshell Membrane
Formulation #0505, 500 mg, once daily, orally
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Oklahoma | |
Leu Private Practice | |
Jenks, Oklahoma, United States, 74037 |
Principal Investigator: | Michael D Leu, D.Ph., N.D. | Unaffiliated |
Study Director: | Kevin J Ruff, Ph.D., MBA | ESM Technologies, LLC |
Responsible Party: | ESM Technologies, LLC. ( Kevin Ruff - Technical Director ) |
Study ID Numbers: | CLN# C0104 |
Study First Received: | September 10, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00750854 |
Health Authority: | United States: Institutional Review Board |
arthritis osteoarthritis fibromyalgia connective tissue disorder |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Fibromyalgia Osteoarthritis |
Joint Diseases Arthritis Connective Tissue Diseases Pain Rheumatic Diseases |
Nervous System Diseases |