Antibody response after Covid-19 vaccine alongwith Kabasura Kudineer
- Conditions
- normal individuals coming for COVID vaccination
- Registration Number
- CTRI/2021/05/033857
- Lead Sponsor
- Sri Sri Institute of Advance Research
- Brief Summary
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|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.
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|Using a double blind, randomized controlled trial having two arms, the experimental group A after Covaxin COVID vaccine will additionally receive **Kabasura Kudineer***500 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.
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|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
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|**Primary outcome measure**would be change from baseline in count of antibodies following first vaccine, second vaccine and at 6-8 weeks after 2nd dose.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 500
- Inclusion criteria -Persons without a history of SARS-CoV-2 infection -Participants yet to receive Covid-19 vaccine.
- Residence within a 10-kilometre radius of AIIMS hospital.
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 Change from baseline in antibodies count following 4 weeks after first dose of vaccine, 4 weeks after second dose of vaccine and at 6-8 weeks after 2nd dose. Baseline, 4 weeks after first dose of vaccine, 4 weeks after second dose of vaccine and 6-8 weeks after 2nd dose of vaccine.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AIIMS New Delhi
🇮🇳South, DELHI, India
AIIMS New Delhi🇮🇳South, DELHI, IndiaAnju DhawanPrincipal investigator9818329539dranjudhawan@gmail.com