Evaluate the medicinal effects of both Ayurveda combinations Bio-Immune as Anti-viral and Covalix Vaccoil as alternate to Vaccine of COVID-19 on exposed individuals and Covid19 contact.

Not Applicable

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/08/027084
• Lead Sponsor: eaf BioLab Leaf Research Institute A Unit of Young Naturalist Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects must be divided into two major groups:

A) Controlled Group

B) Uncontrolled Group

Control Group:

Healthy Individuals

Proven cases of SARS2 nCoV with or without other health issues like COPD, DM, HTN etc

Uncontrolled Group:

Asymptomatic patients who are not SARS2 nCoV positive, which can be either those who tested negative or normal public.

Exclusion Criteria

1. Patients who are taking radiation therapy

2. Patients with sepsis, HIV, Autoimmune

3. Patients on ventilator (critical SARS2 nCoV patients, who used any drug in treatment process)

4. Patients below age of 5 years

5. Patients with nerve disorder

6. History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study

7. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection

8. Clinically significant congenital anomaly of the respiratory tract

9. Inability to take oral medication

10.Prolonged QTc-interval in baseline ECG ( >500 ms)

11. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis

12. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the treatment period.

13. Participation in another research study involving an investigational agent within 30 days prior to consent

14. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

15. Patients not willing to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical cure rate: Time to get a negative status from SARS2 nCoV (defined as viral load of respiratory and serological specimen negative for two consecutive times when tested in an interval of two days)Timepoint: 30 days

Secondary Outcome Measures

Name	Time	Method
1.Duration of fever and each of the respiratory symptoms <br/ ><br>2.Improvement in hematological and laboratory parameters , <br/ ><br>3.No of cases Reporting any ADR/AE <br/ ><br>4.Number of patients referred. <br/ ><br>5.Number of cases that required invasive or non-invasive oxygen therapy during the intervention. <br/ ><br>6.Number of cases that progressed to multi- organ failure while under clinical trial. <br/ ><br>7. Serological survey of patients after applied of Bio-Immune & Covalix Vaccoil .Timepoint: 35 days