Antibody response after COVID 19 vaccine provided along with ayurvedic medicine (NOQ19)

Not yet recruiting

Conditions: normal health persons

Registration Number: CTRI/2021/12/038587

Lead Sponsor: Sri Sri Institute of Advance Research SSIAR

Brief Summary: coronavirus disease 19 (COVID-19) pandemic is unprecedented and has posed a humongous global challenge to human health and the entire healthcare system. As of 04 May 2021, there have been over 20 million (2 crore) cases of COVID-19 in India and more than 153 million cases globally. During the recent second wave, there has been a continuous rise in COVID-19 cases in various states of India. At present several allopathic drugs are under investigation for treatment of coronavirus disease, but they are failing to contain the spread of virus effectively. No allopathic drug has been proven as a cure so far.

There are many   systems of medicine that are known to increase the immunity and act as immune modulators or to treat the diseases. The Indian ayurveda system of medicine is one of such traditional form of indigenous medical system practiced in India for centuries with considerable success. Many ayurvedic herbal medicines have beneficial effects, particularly in respiratory disorders.   Most of these herbal medicines constitute a wide variety of alkaloids, flavonoids, phenols, tannins and volatile oils which commonly show anti-viral and anti-bacterial properties. In-silico evaluation of a range of herbs has shown strong scientific antiviral and immune enhancing value of ayurvedic herbs. The main protease (Mpro) of SARS-CoV-2 is a key enzyme of coronaviruses and has a pivotal role in mediating viral replication and transcription, making it an attractive drug target for SARS-CoV-2 infection. Thus polyherbal formulations that have been approved for use for any respiratory infections can be re-purposed to prevent and treat COVID patients.  The NOQ19 polyherbal formulation is one such formulation and available in form of a tablet.

Studies have been conducted to evaluate the mechanism of action of the herbs in NOQ 19 TABLET.    Withanoside V which is present in the plant Ashwagandha(*Withania somnifera)* is a potent inhibitor of Mpro of SARS-CoV-2, and so proposed as a herbal treatment for COVID-19. Yashtimadhu(*Glycyrrhiza glabra)* has shown to have potential to bind against spike glycoprotein and non-structural protein-15 of SARS COV-2 *in-silico*. These proteins are essential for viral infections and replications. So it has been suggested for prevention and management of COVID-19.

The present study has been planned to measure the immune-modulating properties of the Covid-19 vaccine when provided along with NOQ19-by measuring the antibody response .

It is a double blind, randomized controlled trial. It will have two arms, the experimental group A after COVID vaccine will additionally receive **NOQ19** *500 mg 1 tablet to be taken twice orally* in the morning and evening after food. The control group B will receive COVID vaccine   with a placebo. Both respondents and   investigators will be unaware of the group to which they will be assigned. A total of 500 participants will be recruited following inclusion/exclusion criteria, using a 1:1 allocation ratio, 250 participants will be randomized into each arm.

Antibody test levels will be measured at baseline, 4 weeks after the first dose, 4 weeks after 2nd dose and 8 weeks after 2nd dose ( 4 times).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Participants yet to receive Covid-19 vaccine Residence within a 10-kilometre radius of AIIMS hospital.

Exclusion Criteria

Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or chronic or acute renal failure or any major systemic illness Patients on Immuno-suppression therapy Pregnant Women or lactating mothers.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary - Change from baseline in count of antibodies following first dose of vaccine, second dose of vaccine	4 times, Baseline, after first dose of vaccine, after second vaccine dose,8 weeks after second dose of vaccine

Secondary Outcome Measures

Name	Time	Method
Any adverse effects, Refusal rates

Trial Locations

Locations (1): AIIMS, Delhi
🇮🇳
South, DELHI, India
AIIMS, Delhi
🇮🇳South, DELHI, India
Anju Dhawan
Principal investigator
01126593236
dranjudhawan@gmail.com