OsteoarthritisNCT00750854
Efficacy & Safety Study of Natural Eggshell Membrane (NEM) for the Treatment of Joint & Connective Tissue Disorders
A study testing NEM Formulation X and NEM Formulation Y in people with Osteoarthritis and Fibromyalgia, run by ESM Technologies, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis, Fibromyalgia
- What is being tested?
- NEM Formulation X and NEM Formulation Y
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Apr 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Arm Study to Evaluate the Effectiveness of NEM Compositions for the Treatment of Joint and Connective Tissue Pain
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.
Read the 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.
- Conditions
- Osteoarthritis, Fibromyalgia
- Being tested
- NEM Formulation X, NEM Formulation Y
- Keywords
- arthritis, osteoarthritis, fibromyalgia, connective tissue disorder
- Medical subject headings
- Osteoarthritis, Fibromyalgia, Arthritis, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEM Formulation XDietary supplement
Also called Natural Eggshell Membrane
see Treatment Arms
NEM Formulation YDietary supplement
Also called Natural Eggshell Membrane
see Treatment Arms
| Study group | Role | What they receive |
|---|---|---|
| NEM Treatment 1 | Experimental | NEM Formulation X (#0802), 500 mg, once daily, orally Receives: Dietary Supplement: NEM Formulation X |
| NEM Treatment 2 | Experimental | NEM Formulation Y (#0505), 500 mg, once daily, orally Receives: Dietary Supplement: NEM Formulation Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 & 30 days
Secondary outcomes (1)
A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
Measured: 7 & 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startNov 2003
- Primary completionFeb 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESM Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D Leu, D.Ph., N.D., Principal investigatorKevin J Ruff, Ph.D., MBA, Study director, ESM Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750854
- Sponsor's protocol ID
- CLN# C0104
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2008
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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 2009 Jun 9.
PubMed 19554094
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Arm Study to Evaluate the Effectiveness of NEM Compositions for the Treatment of Joint and Connective Tissue Pain
- ClinicalTrials.gov ID
- NCT00750854
- Acronym / sponsor ID
- CLN# C0104
- Conditions
- Osteoarthritis, Fibromyalgia
- Keywords
- arthritis, osteoarthritis, fibromyalgia, connective tissue disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ESM Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 11 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEM Treatment 1 | Experimental | Dietary Supplement: NEM Formulation XNEM Formulation X (#0802), 500 mg, once daily, orally |
| NEM Treatment 2 | Experimental | Dietary Supplement: NEM Formulation YNEM Formulation Y (#0505), 500 mg, once daily, orally |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEM Formulation XAlso: Natural Eggshell Membranesee Treatment Arms | Dietary supplement | NEM Treatment 1 |
| NEM Formulation YAlso: Natural Eggshell Membranesee Treatment Arms | Dietary supplement | NEM Treatment 2 |
Primary outcome
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
1 secondary outcome
A secondary objective of the study was to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.
Time frame: 7 & 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 19554094Ruff 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 2009 Jun 9.
- Study published in Clinical Interventions in AgingLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Leu, D.Ph., N.D. principal investigator
Kevin J Ruff, Ph.D., MBA study director
ESM Technologies, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEM Formulation X and NEM Formulation Y in people with Osteoarthritis and Fibromyalgia, run by ESM Technologies, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.