Clinical trial NCT02800759: Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain
Official title: The Minimal Effective Dose of Cis-9-cetylmyristoleate (CMO) in Persons Presenting With Knee Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Intermittent
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC). Nutraceuticals containing CMO are used to improve knee pain despite the lack of placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial is to explore the minimal effective dose of CMO for relieving knee joint pain.

Detailed description: Methods: Twenty-eight subjects, who are clinically or radiologically diagnosed as having mild degree arthritic knee joint pain, are randomized into 3 groups; Groups A, B, C that contained 100%, 80%, and 62.4% of fatty acid component with 12.5% of Cis-9-cetylmyristoleate (CMO), and control Group D (starch 100%). The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.

Eligibility criteria: Inclusion Criteria:

* sub-healthy persons \>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4.

Exclusion Criteria:

* current medication use related to arthritis;
* current use of FAC containing products;
* clinical or radiological diagnosis as moderate degree arthritis accompanied by peri-articular spur formation, irregular joint margin, and/or subchondral cyst;
* previous history of knee surgery;
* pregnant, breastfeeding, or practicing contraception with reliable methods, or not accepting our guidelines during the research periods;
* major pain other than knee joint pain;
* current treatment of gastritis or gastric ulcer;
* abnormal screening laboratory results;
* major cardiac, renal disease, or disability that could affect adverse effect assessment or interfere with study completion when enrolled;
* history of major procedures or operations that might affect study results;
* enrollment in another clinical trial or human application testing; and
* judged as unsuitable for human application testing.

Primary outcomes:
measure: CHANGE of Pain
timeFrame: change from baseline at 3 months
Secondary outcomes:
measure: difference in NRS pain score from baseline within groups
timeFrame: at 1-month follow-up, at 2-month follow-up, and at 3-month follow-up
measure: change of the WOMAC score
timeFrame: change from baseline at 3 months
measure: Global Impression of Change
timeFrame: at 3-month follow-up
Other outcomes:
Locations:
Study officials:
References:
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