CTRI/2021/06/033980已完成3 期
A study of efficacy of NOQ19 with standard of care in adults with COVID-19 infection: A randomized, double-blind placebo-controlled clinical trial
Ved Vignan Maha Vidya Peeth Sri Sri Institute of Advanced Research0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
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
- •Screened participants with ‘Yes’ answer to all the following questions will be eligible to take part in the study:
- •a) Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR positive test in sample collected <72 hours prior to randomization. RT-PCR Positive in sample collected > 72 hours prior to randomization with inability to obtain repeat sample and progressive disease suggestive of ongoing SARS-CoV-2 infection.
- •(b)Illness of any duration and considered as SARS-CoV-2 infection by physician on HRCT scan or clinically on SpO2levels requiring supplemental oxygen or ventilation or Rapid Antigen test
- •(c)Male or non-pregnant female adult =18 years of age at time of enrollment
- •(d)Subject (or legally authorized representative)provides informed consent prior to initiation of any study procedures
- •(e)Subject (or legally authorized representative)understands and agrees to comply with planned study procedures
- •(f)No contraindications to NOQ19 – Ayurvedic Proprietary Medicine, such as allergy.
- •Close contact eligibility: All possible eligible contacts willing to participate in the study and provide written consent to follow the study protocol will be tested using RT-PCR for the contact sub-study. If a close contact is positive then they will be screened for eligibility in the main study (Figure 1). If the close contacts are negative then they will be eligible for the contact sub-study, provided they have no contraindications for herbal medications, history of gastritis or peptic ulcer.
排除标准
- •Screened patients with ‘Yes’ answer to any of the following questions will not be eligible to participate in the study:
- •(a)Treating physician considers the patient unfit to administer the intervention (eg. Severe cases with Intubation, on ventilator, multi-organ failure)
- •(b)History of recent gastritis, peptic ulcer or hematemesis
- •(c)Enrolled in another trial
研究者
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