A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19: Community Based Participatory Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time to COVID-19 symptoms relief
研究概览
简要总结
The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach.
CBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),
- •With mild or moderate manifestations of COVID-19
- •Willing to participate, and consent by signing the informed consent and not involved in another clinical trial during the study period
排除标准
- •Patients suffering from severe COVID-19 Disease as judged by WHO criteria (REF)
- •Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit
- •Patients with ongoing immunosuppressive therapy for any reasons for example solid organ transplantation, autoimmune diseases or cancer.
- •Patients with known long term infection like HIV
- •Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
- •Pregnancy and lactation
- •Ayurveda practitioner decision that involvement in the study is not in the patient's best interest
结局指标
主要结局
Time to COVID-19 symptoms relief
时间窗: Up to 14-days
Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale
Prevention of severe stage of Covid19
时间窗: Up to 14-days
Deterioration in clinical status from mild/moderate to severe/critical during the study period assessed by AiM COVID-19 App
次要结局
- Side effect/ adverse events(Up to 14-days)
- COVID-19 severity worsening(Up to 14-days)
- Time to negative saliva(Up to 14-days)