Osteoarthritis Clinical Trial
Official title:
A Double Arm Study to Evaluate the Effectiveness of NEM Compositions for the Treatment of Joint and Connective Tissue Pain
NCT number | NCT00750854 |
Other study ID # | CLN# C0104 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2003 |
Est. completion date | April 2004 |
Verified date | September 2023 |
Source | ESM Technologies, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 2004 |
Est. primary completion date | February 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Leu Private Practice | Jenks | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
ESM Technologies, LLC |
United States,
Ruff KJ, DeVore DP, Leu MD, Robinson MA. Eggshell membrane: a possible new natural therapeutic for joint and connective tissue disorders. Results from two open-label human clinical studies. Clin Interv Aging. 2009;4:235-40. doi: 10.2147/cia.s5797. Epub 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®. | 7 & 30 days |
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