Descriptive Study for the Management of Joint Pain Associated With Osteoarthritis of the Knee: Association of Extracts of Curcuma Longa, Boswellia Serrata and Porphyra Umbilicalis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Percentage of patients reaching the acceptability threshold of their state
研究概览
简要总结
The aim of the study is to evaluate at 3 months the effect of a supplementation with extracts of Curcuma longa, Boswellia serrata and Porphyra umbilicalis on the acceptability of pain for patients suffering from gonarthritic pain.
详细描述
For this study, 126 patients are going to be included. They will have a supplementation of Cartimotil Fort®, from 1 to 4 capsules per day during 90 days.
on the one hand, during the two visits (inclusion and follow-up), the investigator completes the questionnaire about neuropathic pain (DN4).
on the other hand, patients complete the Osteoarthritis Symptom Inventory Scale (OASIS) 4 times : just after the inclusion visit, at day 30, at day 60 and just before the follow-up visit (day 90). He completes the Patient Global Impression of Improvement (PGII), the Minimal Clinically Important Improvement (MCII) and the Acceptable Symptomatic Statement (PASS) 6 times : just after the inclusion visit, at day 10, at day 20, at day 30, at day 60 and just before the follow-up visit (day 90).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VAS of pain : minimum 5/10 on walking or 4/10 at rest
- •Patients with a negative PASS (patient considering that the symptomatic state is not acceptable)
- •Suffering from mono or bilateral femoro-tibial knee osteoarthrosis with painful seizures (confirmed by a radio of less than two years: stage 2 or 3 on the Kellgreen scale - clinical examination)
- •Having agreed to participate in the investigation after receiving information from the investigator
排除标准
- •Patients with rheumatological disorders other than osteoarthritis
- •Patients for whom knee surgery is planned within 3 months
- •Patients who started treatment with chondroitin sulphate (or all treatments of osteoarthritis other than anti-inflammatories and analgesics) for less than one month
- •Patients with a BMI greater than 35
- •Patients with chronic pain that can interfere with knee osteoarthritis pain
- •Patients with reduced mobility or bedridden
- •Patients with cognitive impairments not able to participate in the study
- •Patients with known allergies to any of the ingredients of Cartimotil Fort®
- •Pregnant or breastfeeding patients
- •Patients who do not wish to participate in the study.
结局指标
主要结局
Percentage of patients reaching the acceptability threshold of their state
时间窗: day 30
Percentage of patients reaching the acceptability threshold of their state between D0 and D30 measured by the binary response of the PASS (yes = acceptable).
次要结局
- Yes answer for the PASS(Day 90)
- OASIS Score(Day 90)