Clinical trial NCT05150782: The Effect of Micellized Food Supplements on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-acute COVID-19 Syndrome
Keywords: micelles
dietary supplements
Lead sponsor: PhysioMetrics
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm intervention
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in health-related quality of life
timeFrame: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Secondary outcomes:
measure: Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS).
timeFrame: Week 1, 2, 3, 4, 5, 6, 10 and 14.
measure: Change in general health status
timeFrame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
measure: Change in general health
timeFrame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
measure: Change in Post COVID functional status measured with the 'Post COVID Functional Status' (PCFS).
timeFrame: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Other outcomes:
measure: Course of general health
timeFrame: Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
Locations:
Study officials:
affiliation: Cognitive Health Platform AG
name: Denis Kangeldi, MSc
role: STUDY_DIRECTOR
References: