Status:
COMPLETED
Efficacy & Safety Study of Natural Eggshell Membrane (NEM) for the Treatment of Joint & Connective Tissue Disorders
Lead Sponsor:
ESM Technologies, LLC
Conditions:
Osteoarthritis
Fibromyalgia
Eligibility:
All Genders
18-100 years
Phase:
NA
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.
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 popu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00750854
Start Date
November 1 2003
End Date
April 1 2004
Last Update
September 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leu Private Practice
Jenks, Oklahoma, United States, 74037