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

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.

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.