Efficacy of Tablet AOIM - Z in Prevention of COVID - 19 in High Risk Healthy Police Personnel

Phase 4

Registration Number: CTRI/2020/05/025222

Lead Sponsor: Shree Dhootapapeshwar Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Healthy, Male or Female participants between the age group of 21 to years to 55 years (both inclusive).

Healthy police personnel will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring and treatment.

2.Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements

Exclusion Criteria

1.Pregnant and Lactating females

2.Participants who have been quarantined or confirmed of having COVID-19 and have been isolated for its treatment. Participants having recently suffered and recovered of COVID-19 will also be excluded from the study

3.Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening

4.Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.

5.Participants taking steroid treatment and or any kind of immunosuppressive therapy

6.Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.

7.Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of Incidence of COVID â?? 19 infection in study participantsTimepoint: 6 weeks(45 days) and 12 weeks (90 days)

Secondary Outcome Measures

Name	Time	Method
a)Comparative assessment of severity of COVID-19 (if it occurs) in study participants <br/ ><br>b)Comparative assessment of incidence and severity of allergic conditions (non-infective) leading to sneezing, running nose, sore throat etc. <br/ ><br>c)Comparative assessment of changes in Quality of life and overall health <br/ ><br>d)Safety assessment by incidence of any adverse events in study participants <br/ ><br>Timepoint: 90 Days