A randomized placebo controlled multicentric study to evaluate the efficacy and safety of Ayurvedic formulation as an immunomodulator in reducing the risk of COVID 19 infection or severe stage coronavirus disease in Healthcare workers involved in care of patients with Coronavirus disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To evaluate if Ayurveda Rasayana therapy can prevent symptomatic coronavirus disease or
研究概览
简要总结
Hypothesis: SARS-CoV-2 is a rapidly spreading viral infection causing coronavirus disease. The current strategy for dealing with this pandemic is to identify infected cases and their contacts, screening, isolation, and quarantine to stop spread of the disease. Post exposure to COVID -19 the standard of care is observation of the individual under quarantined condition. Therapy is generally not given to persons who are not hospitalized. Ayurveda medicines have a long-term history of use in clinics for overall immunity building. This has created evidence for its efficacy in various respiratory disorders and also safety is demonstrated. Administration of oral Ayurveda Rasayana formulations will help reduce the risk of development of symptomatic corona virus disease or can prevent disease progression, thereby decreasing hospitalizations and symptoms severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 18 years or older 2 If an individual has come in close contact with someone who has been diagnosed with COVID 19 with last exposure within the last 4 days and do not have any symptoms or 3 A healthcare worker involved in care of patients with Coronavirus disease.
排除标准
- •1 Immunocompromised patients or patients receiving immuno-compromised medications 2 Patients with active malignancy or undergoing anticancer therapies 3 Pregnant women or women who are breastfeeding 4 Consideration by the investigator for any reason that the subject is an unsuitable 5 candidate to receive study treatment Patients not willing to participate in study.
结局指标
主要结局
To evaluate if Ayurveda Rasayana therapy can prevent symptomatic coronavirus disease or
时间窗: Day 1 | Day 30 and | Day 60
severe corona virus disease after known exposure to the SARS-CoV-2 coronavirus
时间窗: Day 1 | Day 30 and | Day 60
次要结局
- Evaluation of Pro inflammatory cytokines.(Disease severity on an ordinal scale.)