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

NCT ID: NCT05150782

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2022-10-10

Brief Summary

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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

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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.

Conditions

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Post-acute COVID-19 Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Curcumin/Boswellia Serrata/Ascorbic acid mixture

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

Group Type EXPERIMENTAL

Curcumin/Boswellia Serrata/Ascorbic acid mixture

Intervention Type DIETARY_SUPPLEMENT

The daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%).

Interventions

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Curcumin/Boswellia Serrata/Ascorbic acid mixture

The daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PhysioMetrics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis Kangeldi, MSc

Role: STUDY_DIRECTOR

Cognitive Health Platform AG

Central Contacts

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Maurice de Graaf, MSc

Role: CONTACT

+41 32 530 52 84

Liana S de Graaf

Role: CONTACT

+41 79 936 57 77

Other Identifiers

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MyCellVSLongCOVID

Identifier Type: -

Identifier Source: org_study_id

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