Reducing the risk of developing symptomatic Corona virus disease and reducing requirement of hospitalization by administering Ayurveda Rasayana therapy as a prophylactic therapy to individuals residing Coronavirus Hotspots and having comorbidities which increases the risk of developing severe stage Coronavirus disease or ARDS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of individual becoming positive as determined by PCR or any other approved commercial or public health assays
研究概览
简要总结
Background:
The Coronavirus disease (COVID-19) is spreading at a great speed and has become a global pandemic. Currently in absence of any approved therapy in India to treat this disease, efforts are being made to reduce transmission via standard public health interventions based on isolation of cases and tracing of contacts. It is Predicted that such a strategy could contribute to reducing the overall size of an outbreak, but will still be insufficient to achieve outbreak control.
Current evidence suggests that patients with any co- morbidity yield poorer clinical outcomes than those without. A greater number of comorbidities also is correlated with poorer clinical outcomes.
Considering the poor outcomes and high mortality rates in patients with comorbidities and limitations of standard public health interventions in limiting the spread of disease it is very important to develop prophylactic therapy for individuals with comorbidities.
This is a single arm, multicentric clinical study
Hypothesis: Administration of oral Ayurveda Rasayana formulations will help reduce the risk of development of symptomatic or severe stage Corona virus disease in individuals with comorbidities and residing in Corona virus Hotspots.Participants will be provided with study medication thrice daily for 30days.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Individuals residing in Corona virus Hotspots as declared by Authorities 2 Individuals having any of the following comorbidities 3 Chronic Diabetic with more than 5 yearsof knownon set Chronic hypertensive with more than 5years of knownon set Patients with active malignancies or taking or taken anticancer therapy within last 6months Patients with chronic lowerrespiratory disease Patients with chronic liver or renalfailure Patients having immunosuppressivetherapies Or elderly person above 65 years of age with or without any comorbidities.
排除标准
- •Pregnant women or women who are breast feeding Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive study treatment.
结局指标
主要结局
Incidence of individual becoming positive as determined by PCR or any other approved commercial or public health assays
时间窗: Time Frame on day 30 or development of symptoms of corona virus disease | Severe stage
次要结局
- Secondary outcomes(Disease severity on an ordinal scale assessed on at weekly intervals telephonically.)