The Effect of a Mixture of Micellized Curcumin/Boswellia Serrata/Ascorbic Acid on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Change in health-related quality of life
研究概览
简要总结
Food supplements like curcumin and boswellia serrata have been used traditionally for anti-inflammatory purposes. A well-known problem of these substances in their natural form is the low bioavailability. Micellization of these substances has been shown to increase the bioavailability significantly and thereby the clinical efficacy. The clinical value of these micellized substances has been presented in numerous clinical studies and in particular in patients with acute COVID-19. This study aims to examine the effect of a mixture of micellized curcumin, boswellia serrata and ascorbic acid on patients with long COVID.
详细描述
The participants will be asked to take the micellized supplements daily, at home for 6 weeks. During this 6 weeks several questionnaires will be taken to asses general health-related quality of life. Follow-up measurements will be done at 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed SARS-CoV-2 infection at least 28 days prior to study participation
- •Patients who are experiencing symptoms of PACS (with a PCFS of 1 or higher)
- •18 years or older and younger than 85
- •Good understanding of written German
排除标准
- •Currently under pharmacological treatment for PACS
- •Any planned medical surgery or intervention where medication intake is necessary in the coming 14 weeks
- •Allergy to curcumin or Boswellia
- •Active malignancy
- •Medical history of Human Immunodeficiency Virus (HIV) infection, or any serious immunocompromised state.
- •Pregnancy (or planned pregnancy in the coming 14 weeks) ( - Patients who are taking anticoagulants or have diabetes type I or II are only allowed to participate if their general practitioner is informed)
结局指标
主要结局
Change in health-related quality of life
时间窗: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Health-related quality of life is measured with the 'Short-Form 12' (SF-12) from 0 to 100, where higher scores on the SF-12 represent better health-related quality of life.
次要结局
- Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS).(Week 1, 2, 3, 4, 5, 6, 10 and 14.)
- Change in general health(Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
- Change in general health status(Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
- Change in Post COVID functional status measured with the 'Post COVID Functional Status' (PCFS).(Week 1, 2, 3, 4, 5, 6, 10 and 14.)