“A Prospective, Open label, Randomized-controlled study to evaluate the efficacy and safety of Amrta Karuna Syrup in mildly symptomatic COVID- 19 patientsâ€
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To Evaluate The Safety And Efficacy Of Amrta Karuna syrup In mildly symptomatic COVID- 19 patients
研究概览
简要总结
Amrta Karuna Syrup is a polyherbal formulation which is apotent combination of antivirals, antibacterials and anti inflammatory alongwith adaptogen and rejuvenating ingredients Morinda tinctoria, Azadirachtaindica, Aegle marmalades, Tamarindus indica, have been suggested in thetreatment.
Administration of formulation of the presentinvention was found to stimulate immunological activity in in vitro cellculture studies. Treatment with five doses of formulation of the presentinvention was found to enhance the total amount of cytokines production count.Anti inflammatory cytokine such as IL-4,IL-6, IL-10, IFN gamma are produced in significant amount and estimated usingquantitative method. These results confirm the immunomodulatory activity of compositionof the present invention
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects age group
- •65 years both gender 2.Patients diagnosed with COVID-19 positive mild symptomatic patients (Confirmed by RTPCR).
- •Patients with uncomplicated upper respiratory infection a.Spo2>94% in room air b.Respiratory rate <24 per min c.No evidence of hypoxaemia or breathlessness 3.Subjects willing to give a written informed consent and come for a regular follow up 4.Subject willing to abide by and comply with the study protocol.
排除标准
- •i.Presence of acute hypoxic respiratory failure.
- •ii.Intensive care unit (ICU) stay.
- •Patients who need mechanical ventilation.
- •iv.Category 6 or 5 based on modified 7-category ordinal scale of clinical status.
结局指标
主要结局
To Evaluate The Safety And Efficacy Of Amrta Karuna syrup In mildly symptomatic COVID- 19 patients
时间窗: Day 0 to 14
次要结局
- 1.LDH, TLC, CRP, D-DIMER and RT PCR from baseline to end of the study i.e. 14 days.(2.RT PCR test will do Day 0,Day 7 and Day 10)