Effect of an Ayurvedic Formulation as add-on to standard of care in COVID-19 positive patients in a tertiary hospital
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- No. of days of treatment, hospitalisation, type of care and site of treatment at hospital, oxygen support requirement, days of ventilation required, period of convalescence and return to normal life activity
研究概览
简要总结
The project is aimed to assess the effect in clinical outcomes fromadministering an integrative medicine protocol which subsumes Ayurvedicinterventions as part of the standard of care COVID 19 management versusclinical outcomes in COVID 19 patients being administered standard of carealone with following objectives
Primary objectives: Assessingthe effect of the Ayurveda drug combination of Tinospora cordifolia and Piperlongum in the progression of the disease, its severityand clinical outcome.
Secondary objectives: Studythe progress of the disease in detail and in real-time to develop betterunderstanding of the pathogenesis and different stages of the disease fromAyurvedic perspective, clinical data and observations based on patient responseto interventions.
2. Correlatingthe clinical investigation parameters of different stages of the pathogenesiswith Ayurveda understanding of the sub-stages of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age > 18 years Written Informed consent is documented COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test.
- •Can take oral medicines Mild-moderate grade of the disease Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection.
排除标准
- •Known sensitivity to any of the ingredients Bleeding haemorrhoids Serious stages of the illnesses ICU admitted patients Pre-existing GI symptoms like nausea or vomiting.
结局指标
主要结局
No. of days of treatment, hospitalisation, type of care and site of treatment at hospital, oxygen support requirement, days of ventilation required, period of convalescence and return to normal life activity
时间窗: Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Percentage of patients progressing to serious/critical stage of disease
时间窗: Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
No. of days taken to test negative for COVID, total days to discharge frm hospital
时间窗: Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Progress of disease as per clinical severity score (COCSS)
时间窗: Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Profiling acc to tridosha
时间窗: Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
Defining the disease according to Ayurveda
时间窗: Observed and recorded on all days of the treatment as relevant | Recorded on the days when the investigation is done | Recorded on the days when the medication is changed in type or dose | Recorded as average of pO2 in a day | Recorded as volume of O2 supplied etc
次要结局
- No. of days to first clinical symptoms, and what it is(No. of days to and of GI symptoms and what they are)