Improving therapeutic outcomes in the treatment of mild to moderate corona virus disease in COVID 19 positive patients via oral administration of Ayurveda formulations a randomized placebo controlled multicentric study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of patients progressed to severe stage.
研究概览
简要总结
Background- The Coronavirus disease (COVID-19) spreads is spreading a great speed and has become a global pandemic. Currently in absence of any approved therapy in India to treat this disease. At present more than 150 different drugs are being researched around the world. Most are existing drugs that are being trialled against the virus. The US Food and Drug Administration (FDA) approved limited emergency use for chloroquine and hydroxychloroquine as a treatment for COVID-19. The National Medical Products Administration of China has approved the use of Favipiravir, an anti-viral drug, as a treatment for coronavirus. However, the use of these investigational drugs has still not showed satisfactory outcomes.
In view of the above scenario there is a scope for use of traditional medicine as an addon complimentary therapy along with standard of care (SoC) to improve therapeutic outcomes in patients with mild to moderate corona virus disease.
Hypothesis: Administration of Ayurveda Rasayana formulation along with standard of care therapies will help improve therapeutic outcomes and prevent progression of the disease to severe stage as compared to patients in control groups receiving standard of care and along with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
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 Age 18 to 60 years 2 COVID-19 positive as determined by PCR or other approved commercial or public health assay 3 Willing and able to provide written informed consent prior to performing study procedures.
排除标准
- •1 Participation in any other clinical trial of an experimental treatment for COVID 19 2 Patients with severe COVID 19 disease defined as follows 3 Respiratory distress as determined by ≥30 breaths per min oxygen saturation at rest ≤85% Severe disease complications e g respiratory failure requirement of mechanical ventilation, septic shock or non-respiratory organ failure 4 Patients with deranged liver functions i.e Total bilirubin ≤ 2 Liver enzymes ≤2.5 times Under Normal limits or deranged renal functions i.e Creatinine ≤ 1.5 times Under Normal limits 5 Patients with unstable angina or history of Myocardial infarction or underwent CABG 6 Patients with known diagnosis of COPD 7 Pregnant women or women who are breastfeeding Immunocompromised patients or patients taking immunosuppressant medication or Patients with active malignancy 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 patients progressed to severe stage.
时间窗: Day 0 | Till day 10
•respiratory distress (≥30 breaths per min);
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•oxygen saturation at rest ≤85%;
时间窗: Day 0 | Till day 10
Severe stage defined as
时间窗: Day 0 | Till day 10
•severe disease complications (eg, respiratory failure, requirement of mechanical ventilation, septic shock, or non-respiratory organ failure).
时间窗: Day 0 | Till day 10
次要结局
- Evaluation of Pro inflammatory cytokines.(Disease severity on an ordinal scale.)