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CCRAS begins clinical research on Ashwagandha tablets in COVID 19 vaccinated participants

Nandita Vijay, Bengaluru
Wednesday, December 8, 2021, 08:00 Hrs  [IST]

The Central Council of Research in Ayurvedic Sciences (CCRAS) is now accelerating its efforts to conduct a medically supervised clinical research study entitled ‘A clinical trial of Ashwagandha administration in participants vaccinated against COVID-19’.

This is to ascertain the safety, immunogenicity and protection ofeffectin tablet form. In this regard it is now calling for vaccinated participants in the age-group of 18 to 45 years.

Now CCRAS has finalized the study site at the health centre within the campus of theSavitribhai Phule Pune University.The study aims at investigating the effect of Ashwagandha tablet on the immunogenicity and safety of COVID-19 vaccine.

In this study we plan to administer Ashwagandha tablets for six months to the vaccinated participants against COVID-19. The immunogenicity will be measured by anantibody titer and virus neutralizing ability against COVID-19 vaccine.

An antibody titer is a blood test. It establishes the presence and level of titer type of antibodies in the blood. Such a test is usually done to investigate animmune reaction triggered by antigens in the body. In this case it will be the COVID-19 vaccine.

While those who can participate in the trial being in the age-group of 18 to 45 years will also need to be SARS-CoV-2 RTPCR negative. Further, they should have no co-morbiditiesor be pregnant . Another requirement is that it is applicable for participants who have been vaccinated with the COVID-19 vaccine Covishield within 7 days of the first or second dose.

In addition CCRAS has maintained that the medically supervised clinical research study will ensure that all the details of the participants would be confidential and will be used only for research purposes. The care and attention of the participants would be under a team of qualified doctors. Their symptoms and status will be monitored by using COVID-19 Kavach a mobile application app. In addition, the participants will be offered travel expenses and insurance as per the government norms.

Dr Shashikant Dudhgaonkar and Dr Girish Tilu are the contact sources for the participants to connect with.
According to Professor Bhushan Patwardhan , former Vice Chairman, University Grants Commission and National Research Professor– Ayush, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University

a large number of Indian people have been consuming various traditional medicines in the hope of better protection against COVID-19 infection. Our earlier studies have reported the immunological benefits of Withania somnifera (Ashwagandha) and its potential as a vaccine adjuvant.

“This will be a prospective, randomized, double blind, parallel group, placebo controlled, two arm, exploratory study on healthy volunteers receiving the COVISHIELD vaccine. In addition to the two dose schedule of COVISHIELD vaccine as per national guidelines, participants will be administered 8gm Ashwagandha or placebo tablets respectively per day”, Prof Patwardhan told Pharmabiz.

“We hypothesize that co-administration of Ashwagandha with the COVISHIELD vaccine may enhance the antibody titres particularly after the first dose of the vaccine. A sustained long-term immune response to the vaccine has implications for prevention of reinfection. This study is is carried out under the supervision of chief clinical coordinator Dr Arvind Chopra along clinical investigators from leading hospitals, medical colleges and Ayurveda institutes from Pune, Mumbai, Nagpur, Hasan, Jaipur and Delhi,” stated Prof. Patwardhan.

 

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Harish Lathia Jan 25, 2022 5:34 PM
Thank you and I pray your noble work yields beneficial results. I know there is a saying to the effect that the whole world is a family.
I was wondering if there are any interim intuitive results. I would love to know. Is this research completely different to the India/UK study with a similar objective?
D R Pardeshi Dec 10, 2021 8:54 AM
Dr.Giirish,we, Pratapians are proud of you.You are doing such a Noble Work that is very useful as well as beneficial for all Mankind.Hearty Congratulations.
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