Effect of Ayurveda Spice Mix Tablet for the Prevention of COVID-19 infection in people exposed to Covid 19 and in high risk patients

Phase 1

Registration Number: CTRI/2020/07/026674

Lead Sponsor: Suraj Ayurveda Clinic and Research center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male or female aged 18-75 years

2.Health care workers/Covid Fighters like police/Social workers etc or high risk group patients in public/private hospitals in India or People in areas of risk of SARS-CoV-2 transmission.

3.People exposed to Covid 19 or having Contact history in 14 days

4.Understanding of the aim of the study and, therefore,acknowledging they have not been on any drug aiming atpre exposure prophylaxis against SARS-CoV-2 (COVID-19) since 1st of May 2020 untill 7 days before the study. This also includes drug forHIV.

5.Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause

Exclusion Criteria

1.COVID + Ve Patient with Symptoms of pneumonia/Hospitalized

2.Active hepatitis B infection, HIV infection

3.Renal failure with estimated glomerular filtration rate (GFR) < 60 ml/min) and patients on Hemodialysis.

4.Participant with any immunosuppressive condition or hematological disease

5.Breastfeeding

6.Known allergy to any of the medication used in this trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reducing number of infected patients in health professionals /workers, Covid fighters like police, social workers etc and people exposed Covid 19 or having history of Contact.Timepoint: day 0, day 14, day 28

Secondary Outcome Measures

Name	Time	Method
1.Reduction in numbers of patients and duration of symptoms measured in days and severity of Symptoms of SARS-CoV-2 (COVID-19) confirmed infected participants of SARS-CoV-2 (COVID-19 <br/ ><br>2.Reduction in clinical severity of SARS CoV2 by SpO2%, Temperature, BP etc, Lab testing and Pulmonay Imaging if any <br/ ><br>Timepoint: 1. Reducing Duration of Symptoms in day 0, day 14, day 28 <br/ ><br>2. Change is Spo2%, Temp, BP, Lab testing and Pulmonary Imaging If anyday 0, day 14, day 28