Covid-19NCT04603690
Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19
A study testing Complementary therapy in people with Covid-19, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial summary
The present study is aimed to investigate the treatment benefits of a combination of dietary supplements quercetin, curcumin and vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Complementary therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Aug 2021to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older, of either gender
- Patients must be tested positive for SARS-CoV-2 by RT-PCR within 72 hours prior to enrolment
- Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
- Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
- Patients must be under the care of a Physician for diagnosis of COVID-19
- Patients who have signed informed consent
Who cannot join
- Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
- Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
- Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
- Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
- Patients with gallstone obstruction
- Hypothyroid suffering patients
- Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19
The present study is aimed to investigate the treatment benefits of a combination of dietary supplements quercetin, curcumin and vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.
Read the detailed description
There is currently no specific early-stage therapeutic treatment available for COVID-19.
Dietary supplements curcumin, quercetin and vitamin D3 have shown strong antioxidant, anti-inflammatory/immunomodulatory and broad-spectrum antiviral effects. The present study is focused to test the combination of oral curcumin, quercetin and vitamin D3 supplements as complementary therapy for outpatients with mild to moderate symptoms of COVID-19 infection.
- Conditions
- Covid-19
- Being tested
- Complementary therapy, Standard of care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary therapyDietary supplement
A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days
Standard of careDrug
This arm will receive standard of care as per the hospital guidelines
| Study group | Role | What they receive |
|---|---|---|
| Complementary therapy group | Experimental | This arm will receive a daily supplementation of 168 mg curcumin, 260 mg quercetin and 9 mcg/360 IU of vitamin D3 (cholecalciferol) as add-on to the standard of care for 14-days Receives: Dietary Supplement: Complementary therapy; Drug: Standard of care |
| Control group | Active comparator | This arm will receive standard care alone Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 Negativity by RT-PCR
Number of patients testing negative for COVID-19
Measured: up to 14 days
COVID-19 symptoms improvement
Number of patients with improvement in COVID-19 acute symptoms
Measured: up to 7 days
Secondary outcomes (11)
Improvement in the serum inflammatory marker level
Changes in the serum CRP level
Measured: up to 7 days
Improvement in the serum inflammatory marker level
Changes in the serum D-dimer level
Measured: up to 7 days
Improvement in the serum inflammatory marker level
Changes in the serum LDH level
Measured: up to 7 days
Improvement in the serum inflammatory marker level
Changes in the serum ferritin level
Measured: up to 7 days
Hospitalization rate
Number of patients required hospitalization
Measured: up to 14 days
Length of hospitalization
Number of hospital admission days
Measured: up to 14 days
Length of supplementary oxygen therapy
Patients requirement oxygen at during hospitalization
Measured: up to 14 days
ICU transfer
Numbers of patients progressing to ICU
Measured: up to 14 days
Mechanical ventilation
Numbers of patients requiring mechanical ventilation at hospital
Measured: up to 14 days
All cause mortality
Numbers of hospital mortality
Measured: up to 14 days
Safety and tolerability
Any adverse event due to the investigational treatment
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start16 Aug 2021
- Primary completion31 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, randomized, controlled, open-label and pragmatic trial, comparing the treatment benefits of combination of curcumin, quercetin and vitamin D3 supplements as add-on to standard treatment vs. standard therapy, in mild to moderate symptomatic COVID-19 outpatients, within 48 hours, for testing Positive for SARS-CoV-2.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ikram Din Ujjan, MBBS, PhD, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603690
- Sponsor's protocol ID
- LUMHS/REC/173
- Status last verified
- Mar 2022
- First submitted
- 24 Oct 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ujjan ID, Khan S, Nigar R, Ahmed H, Ahmad S, Khan A. The possible therapeutic role of curcumin and quercetin in the early-stage of COVID-19-Results from a pragmatic randomized clinical trial. Front Nutr. 2023 Jan 18;9:1023997. doi: 10.3389/fnut.2022.1023997. eCollection 2022.
PubMed 36742008
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19
- ClinicalTrials.gov ID
- NCT04603690
- Acronym / sponsor ID
- LUMHS/REC/173
- Conditions
- Covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 27 Oct 2020 (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.
The present study is aimed to investigate the treatment benefits of a combination of dietary supplements quercetin, curcumin and vitamin D3 as add-on therapy to the routine care for early mild symptoms of COVID-19 infection in outpatients setting.
Detailed description
There is currently no specific early-stage therapeutic treatment available for COVID-19.
Dietary supplements curcumin, quercetin and vitamin D3 have shown strong antioxidant, anti-inflammatory/immunomodulatory and broad-spectrum antiviral effects. The present study is focused to test the combination of oral curcumin, quercetin and vitamin D3 supplements as complementary therapy for outpatients with mild to moderate symptoms of COVID-19 infection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, randomized, controlled, open-label and pragmatic trial, comparing the treatment benefits of combination of curcumin, quercetin and vitamin D3 supplements as add-on to standard treatment vs. standard therapy, in mild to moderate symptomatic COVID-19 outpatients, within 48 hours, for testing Positive for SARS-CoV-2.
| Arm | Type | Receives |
|---|---|---|
| Complementary therapy group | Experimental | Dietary Supplement: Complementary therapy, Drug: Standard of careThis arm will receive a daily supplementation of 168 mg curcumin, 260 mg quercetin and 9 mcg/360 IU of vitamin D3 (cholecalciferol) as add-on to the standard of care for 14-days |
| Control group | Active comparator | Drug: Standard of careThis arm will receive standard care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 18 years of age or older, of either gender
- Patients must be tested positive for SARS-CoV-2 by RT-PCR within 72 hours prior to enrolment
- Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
- Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
- Patients must be under the care of a Physician for diagnosis of COVID-19
Key exclusion criteria (8 listed)
- Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
- Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis
- Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
- Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
- Patients with gallstone obstruction
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 |
|---|---|---|
| Complementary therapyA daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days | Dietary supplement | Complementary therapy group |
| Standard of careThis arm will receive standard of care as per the hospital guidelines | Drug | Complementary therapy group, Control group |
Primary outcome
SARS-CoV-2 Negativity by RT-PCR
Time frame: up to 14 days
Number of patients testing negative for COVID-19
COVID-19 symptoms improvement
Time frame: up to 7 days
Number of patients with improvement in COVID-19 acute symptoms
11 secondary outcomes
Improvement in the serum inflammatory marker level
Time frame: up to 7 days
Improvement in the serum inflammatory marker level
Time frame: up to 7 days
Improvement in the serum inflammatory marker level
Time frame: up to 7 days
Improvement in the serum inflammatory marker level
Time frame: up to 7 days
Hospitalization rate
Time frame: up to 14 days
Length of hospitalization
Time frame: up to 14 days
Length of supplementary oxygen therapy
Time frame: up to 14 days
ICU transfer
Time frame: up to 14 days
Mechanical ventilation
Time frame: up to 14 days
All cause mortality
Time frame: up to 14 days
Safety and tolerability
Time frame: up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 36742008Ujjan ID, Khan S, Nigar R, Ahmed H, Ahmad S, Khan A. The possible therapeutic role of curcumin and quercetin in the early-stage of COVID-19-Results from a pragmatic randomized clinical trial. Front Nutr. 2023 Jan 18;9:1023997. doi: 10.3389/fnut.2022.1023997. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary therapy in people with Covid-19, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 Negativity by RT-PCR (time frame: up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603690, which also lists 1 linked publication.
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 23 Mar 2022.