Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain
Not Applicable
Completed
- Conditions
- Knee Pain Intermittent
- Interventions
- Dietary Supplement: 62.4% dose of JOINTRUS®Dietary Supplement: 80% dose of JOINTRUS®Dietary Supplement: JOINTRUS®Dietary Supplement: Starch 100%
- Registration Number
- NCT02800759
- Lead Sponsor
- Seoul National University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 62.4% of JOINTRUS® 62.4% dose of JOINTRUS® After randomization, 62.4% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons \>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period. 80% of JOINTRUS® 80% dose of JOINTRUS® After randomization, 80% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons \>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period. 100% of JOINTRUS® JOINTRUS® After randomization, 100% dose of JOINTRUS® is taken per day for 3 months in 7 sub-healthy persons \>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period. Starch 100% Starch 100% After randomization, starch 100% was taken per day for 3 months in 7 sub-healthy persons \>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
- Primary Outcome Measures
Name Time Method CHANGE of Pain change from baseline at 3 months using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible)
- Secondary Outcome Measures
Name Time Method difference in NRS pain score from baseline within groups at 1-month follow-up, at 2-month follow-up, and at 3-month follow-up change of the WOMAC score change from baseline at 3 months using the Korean version of WOMAC
Global Impression of Change at 3-month follow-up a scale ranging from 1 (very much improved) to 7 (very much worse).