Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy volunteers – a randomized placebo controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Joint pain reported on visual analogue scale
研究概览
简要总结
Objective: Curcuma longahas been widely used in Ayurveda for its medicinal properties and Turmacin wasdeveloped from C. longa as a standardized extract containingturmerosaccharides.In this clinical trial, the effect of Turmacin onknee joint discomfort in healthy adults subjected to strenuous physicalactivity was evaluated.
Design: Double-blind, triple-arm,parallel-group, randomized placebo-controlled trial.
Setting: Healthy participants from an urbantertiary care teaching hospital
Intervention: Healthy participants were randomizedin 1:1:1 ratio to receive either Turmacin 0.5g/1g or placebo once daily for 84days. The participants were subjected to 10-minute strenuous exercise.
Outcome measures: Time to initial pain, final painscore on a visual analogue scale, range of movement (ROM) of knee and the forceof contractions of muscles around the knee joint.
Results: A total of n=90 participants wererecruited. The meanfinal pain scores were significantly lower in the Turmacin 1g and Turmacin 0.5gwhen compared with the placebo from day-7 and day-5 onwards respectively. Thesurvival analysis consistently showed a decreased hazard for early onset ofpain in both the Turmacin groups. On day-84, the difference in mean ROM betweenTurmacin 0.5g and placebo was 4.79 degrees (p=0.008) and that for Turmacin 1gand placebo was 2.34 degrees (p=0.306). The difference in muscle force forisokinetic contractions of the quadriceps at angular velocities of 120 and 180was significant between Turmacin 0.5g and placebo (p=0.002 and p=0.005respectively) while that for Turmacin 1g & Turmacin 0.5g (p=0.206 andp=0.414 respectively) and Turmacin 1g & Placebo (p=0.046 and p=0.037) werenot significant. However, in the within group analysis participants in Turmacin1g group had better preserved muscle functions than Turmacin 0.5g group atangular velocities of 120 and 180 when compared with placebo.
Conclusion: Turmacin (0.5g and 1g) was efficacious when compared toplacebo in increasing the pain threshold and knee ROM in healthy participants withminor adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.Having trauma or surgery histories that have affected the knee.
- •2.Having a disease that results in bad intestinal absorption 3.Women of child bearing age who do not wish to use approved birth control methods during study 4.Being pregnant or breastfeeding.
- •5.Allergic or hypersensitive to turmeric 6.Being participating or having participated in a clinical assay or intervention study within the previous 30 days before inclusion in the study 7.Being unable to follow the guidelines of the study 8.Subjects having liver problems (raised ALT, AST), Heart (abnormal ECG / ECHO), kidney problems (raised creatinine), other muscle related problems (raised creatine kinase).
- •9.Subjects having neurological disorders 10.BMI greater than 32 kg/m2
- •Taking concomitant medication like pain relievers or complements/ multivitamin supplements/ phytotherapeutical products that interfere with the product or outcomes of the study.
- •12.Suffering from any kind of arthritic condition viz., autoimmune, infectious in the knee that could mislead the evaluation.
结局指标
主要结局
Joint pain reported on visual analogue scale
时间窗: days 5,7,28,56,84
次要结局
- Maximal isometric torque will be measured with knee extension from the knee flexed (90 degree) position(Days 1 & 84)
- isometric and isokinetic knee extension for quadriceps and hamstrings at various angular velocity (60 degree/sec to 300 degree/sec)(Days 1 & 84)
- Isokinetic strength assessed in different velocities in random order(Days 1 & 84)