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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100% of JOINTRUS® | Active Comparator | 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. |
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| 80% of JOINTRUS® | Active Comparator | 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. |
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| 62.4% of JOINTRUS® | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JOINTRUS® | Dietary Supplement | 100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate |
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| Measure | Description | Time Frame |
|---|---|---|
| CHANGE of Pain | using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible) | change from baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | using the Korean version of WOMAC | change from baseline at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23646102 | Background | Thiem U, Lamsfuss R, Gunther S, Schumacher J, Baker C, Endres HG, Zacher J, Burmester GR, Pientka L. Prevalence of self-reported pain, joint complaints and knee or hip complaints in adults aged >/= 40 years: a cross-sectional survey in Herne, Germany. PLoS One. 2013 Apr 30;8(4):e60753. doi: 10.1371/journal.pone.0060753. Print 2013. | |
| 22147711 |
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| ID | Term |
|---|---|
| C087638 | cetyl myristoleate |
| C103009 | Reppal PES 100 |
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| Starch 100% | Placebo Comparator | 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. |
|
| 80% dose of JOINTRUS® | Dietary Supplement | 80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate |
|
|
| 62.4% dose of JOINTRUS® | Dietary Supplement | 62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate |
|
| Starch 100% | Dietary Supplement | 0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate |
|
| Global Impression of Change | a scale ranging from 1 (very much improved) to 7 (very much worse). | at 3-month follow-up |
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