The Effect of Micellized Food Supplements on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.

PhysioMetrics

Status: Unknown

Conditions: Post-acute COVID-19 Syndrome

Treatments: Dietary Supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT05150782

MyCellVSLongCOVID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Curcumin/Boswellia Serrata/Ascorbic acid mixture

Experimental group

Description:

The daily intake of 2x10 drops of a mixture of micellized curcumin(2%), boswellia serrata (1,5%) and ascorbic acid (6%).

Treatment:

Dietary Supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixture