The Minimal Effective Dose of Cis-9-cetylmyristoleate (CMO) in Persons Presenting With Knee Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- CHANGE of Pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4.
排除标准
- •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.
研究组 & 干预措施
100% of 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.
干预措施: JOINTRUS® (Dietary Supplement)
80% 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.
干预措施: 80% dose of JOINTRUS® (Dietary Supplement)
62.4% 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.
干预措施: 62.4% dose of JOINTRUS® (Dietary Supplement)
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.
干预措施: Starch 100% (Dietary Supplement)
结局指标
主要结局
CHANGE of Pain
时间窗: 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)
次要结局
- 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)
- Global Impression of Change(at 3-month follow-up)
研究者
Jeeyoun Moon
Clinical Associate Professor
Seoul National University