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

Evaluation of Clinical Efficacy of AOIM â?? Z Tablets for Prevention of COVID â?? 19 Pandemic in High Risk Healthy Police Personnel â?? Single Arm, Open Labelled, Prospective Exploratory Interventional Clinical Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025222

Enrollment

275

Registered

2020-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: AOIM - Z Tablets: One tablet twice a day for 90 days Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Vedvati Bhapkar

D. Y. Patil Deemed to be University, School of Ayurveda

vinay.pawar@dypatil.edu7506631982

Outcome results