A prospective, double blind, randomized clinical study to evaluate the antibody response after Covid-19 vaccine when provided along with Kabasura Kudineer, a siddha medicine

World over, there has been an epidemic of COVID  19 cases with unexplained low respiratory infection caused due to novel coronavirus leading to severe acute respiratory syndrome.  Because of the suddenness in outbreak, no initial recommended treatments for COVID-19 were available and clinicians, world over, have been looking for new or existing options that can help guide prevention and treatment. A vaccine   generates a level of antibodies in the body.  The body’s immune system response to the vaccine can be done by   measuring the level of antibodies it has generated in the body.

AYUSH systems-based complementary and alternative medicine (CAM) have been traditionally used  as a treatment and preventive strategy for several diseases, including respiratory viral infections. Ministry of AYUSH   has issued an “Advisory on Coronavirus†to manage the COVID outbreak comprising of preventive and prophylactic symptom management of COVID-19   based on AYUSH systems of medicine   for immunity boosting and relieving the respiratory symptoms.   The advisory has   suggested AYUSH medicines as add on interventions to the conventional care  and have recommended multi-herbal Siddha concoction   Kaba Sura Kudineer as a symptom specific approach for prevention for fever and respiratory illness.  Its anti-inflammatory, antipyretic and antibacterial activity and its efficacy and safety  are  under study in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms.

The present project is planned to measure the immune-modulating properties of the Covaxin - Covid-19 vaccine when provided along with Kabasura Kudineer by measuring the antibody response.

 

Using a double blind, randomized controlled trial having two arms, the experimental group A after Covaxin COVID vaccine will additionally receive Kabasura Kudineer500 mg 2 tablets to be taken twice orally in the morning and evening after food while control group B will receive Covaxin COVID vaccine with placebo tablets.  250 Participants   using a 1:1 allocation ratio, 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 6-8 weeks after 2nd dose

Primary outcome measurewould be change from baseline in count of antibodies following first vaccine, second vaccine and at 6-8 weeks after 2nd dose.