Complementary Therapy of Dietary Supplements Curcumin, Quercetin and Vitamin D3 for Mild to Moderate Symptoms of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 Negativity by RT-PCR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Complementary therapy (Dietary Supplement)
Control group
This arm will receive standard care alone
干预措施: Standard of care (Drug)
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
干预措施: Standard of care (Drug)
结局指标
主要结局
SARS-CoV-2 Negativity by RT-PCR
时间窗: up to 14 days
Number of patients testing negative for COVID-19
COVID-19 symptoms improvement
时间窗: up to 7 days
Number of patients with improvement in COVID-19 acute symptoms
次要结局
- Improvement in the serum inflammatory marker level(up to 7 days)
- ICU transfer(up to 14 days)
- Hospitalization rate(up to 14 days)
- Length of hospitalization(up to 14 days)
- Mechanical ventilation(up to 14 days)
- All cause mortality(up to 14 days)
- Length of supplementary oxygen therapy(up to 14 days)
- Safety and tolerability(up to 14 days)
研究者
Prof. Dr. Ikram Din Ujjan, MBBS, PhD
Professor of Pathology
Liaquat University of Medical & Health Sciences