CTRI/2018/03/012367已完成1/2 期
Tolerability and efficacy of moderately high dose Turmacin supplementation on joint discomfort among healthy volunteers – open label single arm pilot study
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- joint pain on visual analogue scale after exercise
研究概览
简要总结
Strenuous exercise in healthy individuals specifically sports person’s acts as a mechanical stressor on chondrocytes of knee, shifting the ECM balance towards catabolism. Animal study results with Turmacin, an active polysaccharide ingrediant from Turmeric, have been promising in having an ameliorating effect on joint pain in osteoarthritis models. Hence the current clinical trial is proposed to understand the translational effects of animal study results in humans on acute pain and also to understand effect of moderately high dose Turmacin (2g/day) on joint discomfort in healthy individuals provided stress on the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All consenting adults aged between 18 and 65 years judged by Investigator to be in general good health on the basis of medical history 2.No knee joint discomfort/pain at rest; 3.Must achieve a knee joint discomfort/pain score of at least ≥ 40 mm on visual analogue scale (VAS) for pain after 10 minutes of brisk walk on the stepmill equipment.
排除标准
- •1.Subjects having liver problems (raised ALT, AST), Heart (abnormal ECG / ECHO), kidney problems (raised creatinine), other muscle related problems (raised creatine kinase).
- •2.Subjects having neurological disorders 3.BMI greater than 32 kg/m2 4.Taking concomitant medication like pain relievers or complements/ multivitamin supplements/ phytotherapeutical products that interfere with the product or outcomes of the study.
- •5.Suffering from any kind of arthritic condition viz., autoimmune, infectious in the knee that could mislead the evaluation.
- •6.Having trauma or surgery histories that have affected the knee.
- •7.Having a disease that results in bad intestinal absorption 8.Women of child bearing age who do not wish to use approved birth control methods during study 9.Being pregnant or breastfeeding.
- •10.Allergic or hypersensitive to turmeric 11.Being participating or having participated in a clinical assay or intervention study within the previous 30 days before inclusion in the study 12.Being unable to follow the guidelines of the study.
结局指标
主要结局
joint pain on visual analogue scale after exercise
时间窗: days 5 and 7
次要结局
- adverse effects(days 5 and 7)
研究者
研究点 (1)
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