Post-acute COVID-19 SyndromeNCT05150782
The Effect of Micellized Food Supplements on Health-related Quality of Life in Patients With Post-acute COVID-19 Syndrome.
A study testing Curcumin/Boswellia Serrata/Ascorbic acid mixture in people with Post-acute COVID-19 Syndrome, run by PhysioMetrics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-acute COVID-19 Syndrome
- What is being tested?
- Curcumin/Boswellia Serrata/Ascorbic acid mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2022to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Post-acute COVID-19 Syndrome
- Being tested
- Curcumin/Boswellia Serrata/Ascorbic acid mixture
- Keywords
- micelles, dietary supplements
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin/Boswellia Serrata/Ascorbic acid mixtureDietary supplement
The daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%).
| Study group | Role | What they receive |
|---|---|---|
| Curcumin/Boswellia Serrata/Ascorbic acid mixture | Experimental | The daily intake of 2x10 drops of a mixture of micellized curcumin(2%), boswellia serrata (1,5%) and ascorbic acid (6%). Receives: Dietary Supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Secondary outcomes (4)
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.
Measured: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Change in general health status
Change in general health status is measured with a dichotomous yes or no question.
Measured: 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
Percentage of change of general health is asked for, where 0 represents no change and 100% means complete change,
Measured: 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).
Self-Test for ordinal scaling of degree of post-COVID symptoms with 0 representing no symptoms and 4 several functional limitations.
Measured: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start17 Jan 2022 (estimated)
- Primary completion10 Oct 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm intervention
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PhysioMetrics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Kangeldi, MSc, Study director, Cognitive Health Platform AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150782
- Sponsor's protocol ID
- MyCellVSLongCOVID
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available for researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05150782
- Acronym / sponsor ID
- MyCellVSLongCOVID
- Conditions
- Post-acute COVID-19 Syndrome
- Keywords
- micelles, dietary supplements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- PhysioMetricsUniversity, hospital or other
- Study start
- 17 Jan 2022 (estimated)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm intervention
| Arm | Type | Receives |
|---|---|---|
| Curcumin/Boswellia Serrata/Ascorbic acid mixture | Experimental | Dietary Supplement: Curcumin/Boswellia Serrata/Ascorbic acid mixtureThe daily intake of 2x10 drops of a mixture of micellized curcumin(2%), boswellia serrata (1,5%) and ascorbic acid (6%). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin/Boswellia Serrata/Ascorbic acid mixtureThe daily intake of 2x10 drops of a mixture of micellized curcumin (2%), boswellia serrata (1.5%) and ascorbic acid (6%). | Dietary supplement | Curcumin/Boswellia Serrata/Ascorbic acid mixture |
Primary outcome
Change in health-related quality of life
Time frame: 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.
4 secondary outcomes
Change in patient selected functional limitations in daily life, measured with the 'Patient specific functional scale (PSFS).
Time frame: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Change in general health status
Time frame: 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
Time frame: 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).
Time frame: Week 1, 2, 3, 4, 5, 6, 10 and 14.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Yes. Data are available for researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Kangeldi, MSc study director
Cognitive Health Platform AG
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin/Boswellia Serrata/Ascorbic acid mixture in people with Post-acute COVID-19 Syndrome, run by PhysioMetrics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurice de Graaf, MSc (+41 32 530 52 84, longcovid@physiometrics.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life (time frame: Week 1, 2, 3, 4, 5, 6, 10 and 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.