Clinical Study on Lupin�s Ayurvedic Nasal Spray in COVID-19 patients and household contacts
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/08/036089
- Lead Sponsor
- upin Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 138
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 �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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method