An open label controlled clinical study to evaluate the efficacy of Ayurveda Medicines - Sudarshana churna, Yestimadhu churna and Amrtharista as add on therapy on Symptomatology, Inflammatory Markers and RT-PCR in positive cases of COVID-19 - A Collaborative Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Changes in
研究概览
简要总结
This study is a randomized parallel group open label clinical study comparing the efficacy of add-on Ayurveda intervention (Sudarshana churna, Yestimadhu churna and Amritharista) and Conventional treatment daily for 2 weeks in 52 subjects (26 in each group) in COVID 19 positive patients that will be conducted at Victoria Hospital, Bangalore Medical College and Research Institute, Bengaluru. The primary outcome measures will be changes in COVID 19 symptomatology, RT-PCR and IL-6 at 2 weeks. The secondary outcome measures will be changes in hospital length stay, intensive care unit free days, oxygen saturation and Hospital Anxiety and depression Scale (HADS) at 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients positive for COVID 19 confirmed by RT-PCR.
- •Patients with mild to moderate symptoms (NEWS 2 criteria).
排除标准
- •Patients with 1) Diabetes Miletus.
- •Hepatic dysfunction 3) Renal dysfunction 4) Pulmonary dysfunction 5) Cardiovascular disease 6) Debilitating Neurological disorders.
- •Psychiatric illness.
- •Pregnant and Lactating.
结局指标
主要结局
Changes in
时间窗: 2 weeks
1) COVID 19 Symptomatology.
时间窗: 2 weeks
2) RT-PCR
时间窗: 2 weeks
3) IL-6
时间窗: 2 weeks
次要结局
- Changes in(1) Hospital length stay.)