Efficacy and Safety of NEM® Brand Eggshell Membrane in Patients With Grade 2/3 Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02291757|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Dietary Supplement: NEM brand eggshell membrane Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Single-crossover at 4 weeks|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Efficacy and Safety of NEM® Brand Eggshell Membrane in Patients With Grade 2/3 Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Placebo-controlled, Single-crossover Study|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Active Comparator: NEM brand eggshell membrane
Subjects will be given enough treatment capsules or placebo capsules for 30-days after initial assessment, covering both the 7- and 30-day follow-up visits.
Dietary Supplement: NEM brand eggshell membrane
NEM 500 mg, once daily, p.o.
Other Name: Natural Eggshell Membrane
Placebo Comparator: Placebo
Subjects will be given enough treatment capsules or placebo capsules for 30-days after initial assessment, covering both the 7- and 30-day follow-up visits. At the 30-day evaluation, patients in the placebo group will cross over to the treatment group for the remainder of the study and all patients will be given a 60-day supply of treatment capsules covering the 90-day follow-up visit.
Dietary Supplement: Placebo
Placebo, 500 mg, once daily, p.o.
- Change in Total WOMAC Score from Baseline [ Time Frame: 30 days ]Clinical assessment of OA will be done using the Western Ontario and McMaster Universities Osteoarthritis Index ((WOMAC; v LK3.1: Turkish language translation) in the treatment group versus placebo. Possible score zero up to 96, with lower scores indicating better outcomes.
- Change in Range of Motion (ROM) from Baseline as measured by goniometer [ Time Frame: 30 days ]Measurement of joint range of motion by goniometer in the treatment group versus placebo.
- Safety Evaluations as measured by number of Participants with Adverse Event [ Time Frame: 90 days ]The evaluation of safety and tolerability in all study group and for treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291757
|Akdeniz University School of Medicine|
|Adnan Menderes University School of Medicine|
|Uludağ University School of Medicine|
|Atatürk University School of Medicine|
|İstanbul University Cerrahpaşa School of Medicine|
|İstanbul University İstanbul School of Medicine|
|Marmara University School of Medicine|
|Ordu University School of Medicine|
|Study Director:||Meltem Çakmakgil, Dr.||Generica Pharmaceuticals|