Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers: a Pilot, Randomised, Parallel and Double Blind Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in WOMAC pain subscale
研究概览
简要总结
The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain
详细描述
Join pain is a common cause of consultation in primary health care in the adult population. Indeed, people who suffer knee pain, mostly due to osteoarthritis, require analgesic treatment, often with some secondary effects. Therefore, the research to find a natural and efficient product to reduce knee pain in a short period of time, facilitating recovery after exercise and without side effects have an interest both for industry and for the general population.
B-turmactive is an extract of Curcuma longa mixing two fractions in a single product: a) soluble fraction free-curcuminoids but rich in polysaccharides and b) curcuminoids fraction with cyclodextrin. Both fractions plus vitamin C are B-turmactive.
Previous preclinical studies suggest that B-turmactive could exert an acute effect in healthy people that suffer mild or moderate knee pain and, furthermore could reduce inflammation process.
Therefore, the goal of this study is to assess the short (acute) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between 30 and 65 years old.
- •Score between 15-25 out of 50 within WOMAC pain subscale
- •Signed informed consent.
排除标准
- •people who take concomitant drug or supplements (multivitamins) that could interfere with the product under study.
- •people who suffer froma arthritis of the knee.
- •people who take more than two analgesic drugs and/or anti-inflammatory for more than three months.
- •people who have a history of surgery or trauma affecting the knee.
- •people with gluten sensitivity and/or allergy to gluten and sulphites (the placebo containing yeast).
- •people with anemia (haemoglobin ≤ 13g/dL in men and ≤ 12g/dL in women).
- •people with BMI ≥ 30 kg / m
- •women pregnant or breastfeeding.
- •women with menopausal suffering from osteoporosis.
- •people with liver abnormalities (ALT, AST), kidney (creatinine) or other muscular issues (creatine kinase).
- •people with neurological disorders.
- •people who have participated in a clinical trial or intervention study the last 30 days prior to inclusion in the study.
- •people unable to follow the guidelines of the study.
- •people who not signed the informed consent.
结局指标
主要结局
Change in WOMAC pain subscale
时间窗: 1 week (day 1; day 3; day 7)
Visual analogue scale of 5 items derived from 24 items WOMAC scale
次要结局
- Anthropometric data(1 week (day 1;day 7))
- Inflammatory markers(1 week (day 1;day 7))
- Biochemistry for on-going study control(1 week (day 1;day 7))