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

Primary Purpose

Post-acute COVID-19 Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Curcumin/Boswellia Serrata/Ascorbic acid mixture
Sponsored by
PhysioMetrics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-acute COVID-19 Syndrome focused on measuring micelles, dietary supplements

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Curcumin/Boswellia Serrata/Ascorbic acid mixture

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Change in health-related quality of life
    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.

    Secondary Outcome Measures

    Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS).
    Patient specific limitations in daily life are measured with the 'Patient Specific Functional Scale' (PSFS). The scale is a visual analogue scale ranging from 0 to 100, with 0 meaning no limitations in the patient selected functional activity and 100 means it is impossible to perform this activity.
    Change in general health status
    Change in general health status is measured with a dichotomous yes or no question.
    Change in general health
    Percentage of change of general health is asked for, where 0 represents no change and 100% means complete change,
    Change in Post COVID functional status measured with the 'Post COVID Functional Status' (PCFS).
    Self-Test for ordinal scaling of degree of post-COVID symptoms with 0 representing no symptoms and 4 several functional limitations.

    Full Information

    First Posted
    December 5, 2021
    Last Updated
    December 19, 2021
    Sponsor
    PhysioMetrics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05150782
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 17, 2022 (Anticipated)
    Primary Completion Date
    October 10, 2022 (Anticipated)
    Study Completion Date
    October 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    PhysioMetrics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-acute COVID-19 Syndrome
    Keywords
    micelles, dietary supplements

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single-arm intervention
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Curcumin/Boswellia Serrata/Ascorbic acid mixture
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Name(s)
    Curcumin/Boswellia Serrata/Ascorbic acid mixture
    Intervention Description
    The daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%).
    Primary Outcome Measure Information:
    Title
    Change in health-related quality of life
    Description
    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.
    Time Frame
    Week 1, 2, 3, 4, 5, 6, 10 and 14.
    Secondary Outcome Measure Information:
    Title
    Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS).
    Description
    Patient specific limitations in daily life are measured with the 'Patient Specific Functional Scale' (PSFS). The scale is a visual analogue scale ranging from 0 to 100, with 0 meaning no limitations in the patient selected functional activity and 100 means it is impossible to perform this activity.
    Time Frame
    Week 1, 2, 3, 4, 5, 6, 10 and 14.
    Title
    Change in general health status
    Description
    Change in general health status is measured with a dichotomous yes or no question.
    Time Frame
    Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
    Title
    Change in general health
    Description
    Percentage of change of general health is asked for, where 0 represents no change and 100% means complete change,
    Time Frame
    Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
    Title
    Change in Post COVID functional status measured with the 'Post COVID Functional Status' (PCFS).
    Description
    Self-Test for ordinal scaling of degree of post-COVID symptoms with 0 representing no symptoms and 4 several functional limitations.
    Time Frame
    Week 1, 2, 3, 4, 5, 6, 10 and 14.
    Other Pre-specified Outcome Measures:
    Title
    Course of general health
    Description
    Graphical depiction of course of self-perceived change of general health.
    Time Frame
    Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 , 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maurice de Graaf, MSc
    Phone
    +41 32 530 52 84
    Email
    longcovid@physiometrics.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liana S de Graaf
    Phone
    +41 79 936 57 77
    Email
    info@physiometrics.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Denis Kangeldi, MSc
    Organizational Affiliation
    Cognitive Health Platform AG
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data are available for researchers upon request.
    IPD Sharing Time Frame
    The data will become available as soon as the results are published. The availability of the data is 5 years.
    IPD Sharing Access Criteria
    i) Affiliated researcher, 2) researcher must be able to demonstrate that accessing the raw study data is necessary to be able to conduct his/her research project

    Learn more about this trial

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

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