CTRI/2021/08/036089已完成2 期
Multi-center, randomized, parallel-group, comparative, open-label study to evaluate the efficacy and safety of Lupin�s Ayurvedic Nasal Spray in subjects diagnosed with COVID-19 and household contacts - NI
upin Ltd0 个研究点目标入组 138 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
- 138
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
- •1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol.
- •2. Subjects with mild COVID-19 symptoms (only for Treatment Group). Subjects with uncomplicated upper respiratory tract infection (without shortness of breath or hypoxia [normal saturation i.e. SpO2 levels ââ?°Â¥94%]), may have mild grade of fever ( <1000 C), cough, sore throat, nasal congestion, malaise and headache.
- •3. Participants staying with COVID-19 subject in the same household (only for Prevention Group).
- •4. Participants who have tested positive for RT-PCR (for treatment group only) and negative for RT-PCR (for prevention group only) within 5 days of enrollment
排除标准
- •1. Subjects with moderate to severe disease
- •2. Subjects requiring or likely requiring oxygen support in the opinion of investigator
- •3. Any clinical contraindications, as judged by the investigator
- •4. Pregnant or lactating females
- •5. Subjects with prior history of confirmed COVID-19 infection with RT-PCR in last 3 months.
- •6. Subjects who are currently hospitalized or need for hospitalization
- •7. Subjects with blocked nose requiring intranasal decongestant
- •8. Any history of underlying uncontrolled medical illness (such as diabetes, hypertension, liver disease or history of alcoholism, HIV or any other serious medical illness)
研究者
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