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Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05130671
Recruitment Status : Completed
First Posted : November 23, 2021
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
somia iqtadar, King Edward Medical University

Brief Summary:
The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Standard of care Dietary Supplement: Investigational treatment Not Applicable

Detailed Description:

Flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. They are widely used to boost the immunity against infections and keeping healthy life-style. Results from recent published studies have shown positive results for quercetin and curcumin in patients with COVID-19.

In the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of COVID-19 in community-based patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Benefits of Flavonoids Quercetin and Curcumin Supplements for Mild Symptoms of COVID-19
Actual Study Start Date : October 25, 2021
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of care
This arm will receive the standard of care as per the hospital guidelines.
Drug: Standard of care
Standard of care treatment as per the hospital guidelines

Experimental: Investigational treatment
This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care.
Drug: Standard of care
Standard of care treatment as per the hospital guidelines

Dietary Supplement: Investigational treatment
Combination of quercetin and curcumin as add-on to the standard of care




Primary Outcome Measures :
  1. Testing negative for SARS-CoV-2 by Reverse Transcription Polymerase Chain Reaction (RT-PCR) [ Time Frame: Day 7 ]
    Testing of naso-pharyngeal swab for COVID-19

  2. COVID-19 symptoms improvement [ Time Frame: Day 7 ]
    Improvement of the typical symptoms associated with COVID-19 infection


Secondary Outcome Measures :
  1. Improvement in CRP level [ Time Frame: Day 7 ]
    Improvement in the CRP levels

  2. Improvement in D-dimers level [ Time Frame: Day 7 ]
    Improvement in D-dimers level

  3. Improvement in LDH levels [ Time Frame: Day 7 ]
    Improvement in LDH levels

  4. Improvement in ferritin levels [ Time Frame: Day 7 ]
    Improvement in Ferritin levels

  5. Improvement in full blood count (CBC) [ Time Frame: Day 7 ]
    Improvement in CBC levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be 18 years of age or older, of either gender
  • Patients must be tested positive for SARS-CoV-2 by RT-PCR
  • 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 withshaking, 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

Exclusion Criteria:

  • 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 suppering patients
  • Patients with moderate or severe thrombocytopenia (platelet count <100 ×10⁹/L);
  • Pregnant patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130671


Locations
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Pakistan
King Edward Medical University Teaching Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
King Edward Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: somia iqtadar, Associate Professor of Medicine, King Edward Medical University
ClinicalTrials.gov Identifier: NCT05130671    
Other Study ID Numbers: 785/RC/KEMU/25.10.2021
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases