Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level, multi centric, non-randomized, comparative, interventional community based study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- i. Clinical, psychological and Quality of life assessment
研究概览
简要总结
It is well known that COVID-19 infection influences immunosuppressive people more harshly. Thusly, improving insusceptibility is unquestionably one of the manners in which the specialists over the globe have been utilizing for treating COVID-19 cases. Truth be told, high portions of vitamin C, known to support immunity, have been regulated to the COVID-19 patients in China and other countries with promising outcomes. Indian Council of Medical Research (ICMR) also endorsed the utilization of hydroxyl-chloroquinone for prophylactic treatment of COVID-19 positive cases as of late on March 26, 2020.
Ayurveda makes reference to various resistances boosting therapeutics, one of the incredibly Indian customary medications. The study objectives are the scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female > 18 and < 75 years of age (inclusive).
- •The normal healthy individuals.
- •High risk individuals.
- •Immunosuppressant peoples and subjects with mild to moderate co-morbidities.
- •Non-symptomatic subjects under Institutional and Home Quarantine.
- •Symptomatic subjects under Institutional Quarantine.
- •(Optional, subject to approval from concerned officials and departments)
- •Confirmed COVID-19 cases under isolation and treatment (Optional, subject to approval from concerned officials and departments)
- •Signed ICF.
排除标准
- •Subjects < 18 and > 75 years of age
- •Uncontrolled systemic illness.
- •Hypersensitivity to any component of Investigational Drug.
- •Recent history of drug or alcohol abuse.
- •Pregnant female.
- •Pre-existing GI symptoms like nausea and vomiting.
- •Patients not willing to sign ICF.
- •Individuals with severe co-morbidities.
结局指标
主要结局
i. Clinical, psychological and Quality of life assessment
时间窗: From baseline assessment, 1 week, 2 week and 4 week
ii. Comparative analysis of occurrence of COVID-19 in subjects taking Ayurvedic Interventions and those not taking Ayurvedic Intervention
时间窗: From baseline assessment, 1 week, 2 week and 4 week
iv. Comparative analysis of occurrence of conclusive symptoms of other than non-COVID-19
时间窗: From baseline assessment, 1 week, 2 week and 4 week
iii. Comparative analysis of occurrence of conclusive symptoms of COVID-19 (as per ordinal scale of clinical improvement published by WHO).
时间窗: From baseline assessment, 1 week, 2 week and 4 week
次要结局
- Assesment of laboratory parameters Rapid ELISA COVID 19, PCR COVID 19, Viral Load, T.L.C. D.L.C; Hb% ; E.S.R. ; P.P.B.S., URINE : RE / ME etc.(Incidence of COVID 19 infection in during study period in study population)