Evaluation of the Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in People With Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 134
- 主要终点
- - variation in the level of joint function measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
INTRODUCTION The treatment of OA is mostly symptomatic and includes the use of analgesics, NSAIDs, exercise and even surgery. However, the use of long-term NSAIDs is associated with potentially serious side effects. As a result, the use of alternative and complementary therapies (CAM), such as nutritional therapies in patients with OA, is extremely frequent.
The objective of this study will be to evaluate the effectiveness of a dietary supplement based on curcumin, polydatin and beta-caryophyllene, on the reduction of pain and inflammatory component in individuals with knee OA.
MATERIAL AND METHOD Study design Intervention study with two parallel arms, randomized, double-blind, placebo-controlled.
Study population Participants in the study will be recruited at the Santo Stefano Rehabilitation Institute. The first group will be treated with curcumin-based supplement for 6 weeks; the second group will be treated with placebo for 6 weeks.
Inclusion/exclusion criteria Inclusion criteria
- Presence of osteoarthritis of the knee. Traditional American College of Rheumatology criteria, which are based on the presence of pain (knee pain) plus at least three of the following characteristics, will be used for the diagnosis of osteoarthritis of the knee:
- Age > 50 years
- Stiffness in the morning < 30 minutes
- Presence of articular rusting
- Painfulness of the bones
- Tumefaction of the bones
- Absence of palpable heat Knee pain in this study is defined as having experienced at least moderate pain in the most affected knee (a score of 30 mm or more on an analog visual scale - VAS - as assessed by the patient) for at least 25 of the previous 30 days.
Exclusion criteria
- pregnancy and breastfeeding
- other specific contraindications/intolerances to the compound
- intake of other supplements
- treatment with anti-inflammatory or pain-relieving drugs for other clinical conditions at the time of enrolment
- Participation in other clinical studies All participants will be allowed to use analgesics (e.g. paracetamol) to control pain when needed. The patient will, however, be required to avoid / suspend the use of analgesics at least 12 hours before the baseline visit and subsequent checkups.
详细描述
INTRODUCTION Gonarthrosis is the most common disorder of the musculoskeletal system, with an age-related prevalence varying between 12-55%. The treatment of OA is mostly symptomatic and includes the use of analgesics, NSAIDs, exercise and even surgery. However, the use of long-term NSAIDs is associated with potentially serious side effects, with a high risk of hospitalization and death. As a result, the use of alternative and complementary therapies (CAM), such as nutritional therapies in patients with OA, is extremely frequent.
The objective of this study will be to evaluate the effectiveness of a dietary supplement based on curcumin, polydatin and beta-caryophyllene (FENOXIDOL™-Mivell), on the reduction of pain and inflammatory component in individuals with knee OA.
MATERIAL AND METHOD Study design Intervention study with two parallel arms, randomized, double-blind, placebo-controlled to assess the effectiveness of the dietary supplement in reducing perceived pain, will also be evaluated secondarily the improvement of joint function, changes in serum levels of PCR, inflammatory cytokines (TNF-alpha and IL-6) and nitrates / nitrites at the level of saliva and any change in the use of painkillers when needed.
Intervention Intervention group: the study involves the intake of two capsules per day, one capsule to be taken before breakfast and one before dinner for a period of 6 weeks.
The FENOXIDOL™ supplement and its placebo (visually identical capsules, but without active ingredients) will be supplied by the company Mivell Srls participating in the PrIntAge project. For the composition of the placebo, see the declaration attached to this document by Mivell Srls.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of osteoarthritis of the knee. Traditional American College of Rheumatology criteria, which are based on the presence of pain (gonalgia) plus at least three of the following characteristics, will be used for the diagnosis of osteoarthritis of the knee:
- •Age > 50 years
- •Stiffness in the morning < 30 minutes
- •Presence of articular rusting
- •Painfulness of the bones
- •Tumefaction of the bones
- •Absence of palpable heat
排除标准
- •- pregnancy and breastfeeding (if the potential participant does not declare to be in a menopausal state)
- •other specific contraindications/intolerances to the compounds contained in the supplement (e.g. celiac disease, allergy)
- •simultaneous intake of other supplements
- •to be at the time of enrolment for treatment with anti-inflammatory or pain-relieving treatment for other clinical conditions
- •Participation in other clinical studies
- •State of inability to understand or desire
结局指标
主要结局
- variation in the level of joint function measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: 0, 6 weeks
WOMAC scale is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a 0-4 scale, corresponding to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up; higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
次要结局
- - variation of serum levels of C-reactive Protein (CRP)(6 weeks)
- - variation in the use of painkillers(6 weeks)
- - variations of saliva levels of TNF-alpha, IL-1beta, IL-6, nitrates/nitrites(6 weeks)