NCT05089318已完成不适用
Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience
Tilman S.A.1 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2019年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Pain using a Numerical Rating Scale (NRS)
研究概览
简要总结
The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older dan 45 years old,
- •With hand joint chronic discomfort,
- •Regularly uses of paracetamol or NSAIDs to manage pain,
- •Painful symptoms must have been present for more than 6 months,
- •The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours.
排除标准
- •Related to previous and associated treatments:
- •Corticosteroids injection in the 3 previous months, whatever the joint concerned,
- •Use of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy or homeopathy for hand joint discomfort..),
- •Anticoagulant (coumarinic) treatment and heparin,
- •General corticotherapy in the 3 previous months,
- •Contraindication to paracetamol, curcumin, boswellia and NSAID's.
- •Related to associated pathologies:
- •Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
- •The patient has rheumatoid arthritis or gout,
- •The patient has a bile obstruction.
- •Related to patient:
- •Pregnant or breastfeeding women.
结局指标
主要结局
Pain using a Numerical Rating Scale (NRS)
时间窗: 84 days
Change from baseline of the mean pain over the last 48 hours evaluated by the patient on a 0 to 10 scale ( 0= no pain and 10=maximal pain)
次要结局
未报告次要终点
研究者
研究点 (1)
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