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

NCT ID: NCT05130671

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2021-12-31

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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

This arm will receive the standard of care as per the hospital guidelines.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

Standard of care treatment as per the hospital guidelines

Investigational treatment

This arm will receive combination of nutritional supplements quercetin and curcumin as add-on to the standard of care.

Group Type: EXPERIMENTAL

Standard of care

Intervention Type: DRUG

Standard of care treatment as per the hospital guidelines

Investigational treatment

Intervention Type: DIETARY_SUPPLEMENT

Combination of quercetin and curcumin as add-on to the standard of care

Interventions

Standard of care

Standard of care treatment as per the hospital guidelines

Intervention Type: DRUG

Investigational treatment

Combination of quercetin and curcumin as add-on to the standard of care

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: lead

Responsible Party

somia iqtadar

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Edward Medical University Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Khan A, Iqtadar S, Mumtaz SU, Heinrich M, Pascual-Figal DA, Livingstone S, Abaidullah S. Oral Co-Supplementation of Curcumin, Quercetin, and Vitamin D3 as an Adjuvant Therapy for Mild to Moderate Symptoms of COVID-19-Results From a Pilot Open-Label, Randomized Controlled Trial. Front Pharmacol. 2022 Jun 7;13:898062. doi: 10.3389/fphar.2022.898062. eCollection 2022.

Reference Type: DERIVED

PMID: 35747751 (View on PubMed)

Other Identifiers

785/RC/KEMU/25.10.2021

Identifier Type: -

Identifier Source: org_study_id