Oral Curcumin, Quercetin and Vitamin D3 Supplements for Mild to Moderate Symptoms of COVID-19

NCT ID: NCT04603690

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2022-02-28

Brief 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.

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

Study Design

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

Study Groups

Complementary therapy group

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

Group Type: EXPERIMENTAL

Complementary therapy

Intervention Type: DIETARY_SUPPLEMENT

A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days

Standard of care

Intervention Type: DRUG

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

Control group

This arm will receive standard care alone

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

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

Interventions

Complementary therapy

A daily supplementation of 168 mg curcumin, 260 mg quercetin and 360 IU of vitamin D3 (cholecalciferol) for 14-days

Intervention Type: DIETARY_SUPPLEMENT

Standard of care

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

Intervention Type: DRUG

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 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

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 suffering 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

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Ikram Din Ujjan, MBBS, PhD

Professor of Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Liaquat University Hospital

Jāmshoro, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 36742008 (View on PubMed)

Other Identifiers

LUMHS/REC/173

Identifier Type: -

Identifier Source: org_study_id