CTRI/2020/10/028537已完成2 期
Evaluation of Immuno-Modulatory Potential of Ayurvedic Medicines in Patients with Mild Symptoms of COVID-19: Single Blinded, Randomized and Controlled Study - NI
Shree Baidyanath Ayurved Bhawan Pvt Ltd0 个研究点目标入组 92 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age more than 18 or less than 75 years at time of signing Informed Consent Form.
- •COVID positive by RTPCR
- •Cases that have been assigned as mild or very mild or asymptomatic cases of COVID.
- •Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI).
- •No difficulty in swallowing oral medications.
- •Must agree not to enroll in another study of an investigational agent prior to completion of study.
排除标准
- •Allergies, known to be allergic to research drugs or drug excipients;
- •Subject weight is less than 40 kg
- •Pneumonia with/without signs of severe disease.
- •COVID Cases with ARDS or Septic shock.
- •Patients who have participated in other clinical trials within 1 month.
- •Known patients with impaired renal function (estimated creatinine clearance <60 mL / min
- •During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-ALT or AST level 5 times the upper limit of normal range (ULN) or-ALT or AST more than 3 times ULN and total bilirubin levels more than 2 times ULN.
- •Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
研究者
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