Clinical evaluation of Virunil a standardized ayurvedic herbal compound as an adjuvant in management of COVID-19
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The drug may reduce the hospital stay & inflammatory condition of COVID19 patients
研究概览
简要总结
The study is undertaken to observe the efficacyof Standardized marketed Ayurvedic formulation Maha Sudarshan Churna andextracts of Tulasi, Turmeric and Garlic powders in the management of COVID-19disease patients as an adjuvant therapy in subjects aged between 18 to 65 yearsof both genders who are not having any substantial respiratory complications byassessing the inflammatory markers like Interleukin-6(IL-6), High Sensitive Creactive Protein(HSCRP), Lactate dehydrogenase(LDH), D-dimer, Ferritin,Hs-Troponin–I, and Pro- calcitonin. If it proven efficient it will be very helpful as a supportivetherapy in these pandemic situation of covid 19. By this Ayurveda will play akeyrole in supportive therapy of covid19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
- •Patient who are present in the stages of 1 and 2 of the COVID-19 disease.
排除标准
- •1.Patients with Auto Immune Disorders.
- •2.Patients with Co morbid conditions such as Diabetes Mellitus and Hypertension.
- •3.Patients Under any kind of Anti-Cancer medication, Immunosuppressants.
- •4.Patients who are under anti-platelet medication.
- •6.Patients with compromised pulmonary function.
- •7.Patients receiving antiviral drugs.
- •8.Pregnant and lactating mothers are also excluded from the study.
结局指标
主要结局
The drug may reduce the hospital stay & inflammatory condition of COVID19 patients
时间窗: At base line, 7th day and 10th day
次要结局
- Time from randomization to first time use of high flow supplemental oxygen/non-invasive ventilation/mechanical ventilation/ extracorporeal membrane oxygenation(Randomization to hospital discharge (or day 28, which ever is earlier))