ESIC model Hospital, Kandivali (E)(E), Mumbai

All India Institute of Ayurveda, New Delhi

GS Medical College & KEM Hospital, College building, First Floor, Acharya Donde Marg, Parel, Mumbai

RRAP Central Ayurveda Research Institute for Cancer (CCRAS), Podar Medical Campus, Dr A B Road, Worli, Mumbai

TN Medical College & BYL Nair Hospital, Dr. AL Nair Road, Mumbai Central, Mumbai

Department of General Medicine, IMS, Banaras Hindu University, Varanasi, 221005

Postgraduate Institute of Medical Education and Research, Chandigarh, 160011

Bhausaheb Deshmukh Memorial Medical College, Amaravati 444603

Department of Medicine, King George's Medical University, Lucknow, 226003

Currently there is no definitive pharmacological prophylaxis against COVID-19. ICMR has issued an advisory on the empirical use of HCQ to provide chemoprophylaxis against COVID-19 in high risk participants but has stated that ‘proof of concept and pharmacokinetics studies’ will be required expeditiously and that the advisory may be changed with generation of new evidence. It is against this perspective that the current research proposal for evaluation of Ashwagandha as a prophylactic agent in COVID-19 is considered.
Ayurveda, an Indian traditional system focuses on health promotion and disease prevention. Ayurveda advocates lifestyle management through diet, behavioural interventions and medicinal formulations for strengthening physiological systems and maintaining hemodynamics.  Ayurveda is a public health approach that aims at boosting immune status of people through effective, safe, affordable, and accessible solutions. The holistic interventions of Ayurveda employ several non-pharmacological measures that are critical to overall health and include diet, sleep, mental relaxation, lifestyle behaviour and yoga. Ayurveda interventions have been studied for their clinical benefits in several trials and have been reported safe and effective in various health challenges especially diseases mediated through immune response.

Multidimensional association of SARS-CoV-2 infection with several physiological processes may cause severe disease and severe acute respiratory syndrome characterized by severe hypoxia, multiple organ failure and a florid cytokine storm syndrome. This may lead to early death despite critical care. Undoubtedly, the host immunity is critical to treat the SARS-CoV-2 infection and this may become exuberant and hyper or deregulated to contribute to morbidity and mortality. Recent reports also indicate the possibility of relapse/recurrence of COVID-19 after patients have been declared fully recovered; maybe there is a carrier state.  Thus, there is a need to improve the host immunity and control excess immune inflammatory response. It is against this background that the use of an Ayurveda derived immunomodulation is proposed to control the spread of COVID-19.

Ashwagandha is one of the extensively used Rasayana botanicals in Ayurveda practice since ages. It is a perennial shrub of Solanaceae family and as per classical texts of Ayurveda the roots have the optimum medicinal properties. Our research spanning for more than 25 years has shown that WS has regenerative, adaptogenic, immunomodulant, therapeutic adjuvant, and vaccine adjuvant properties. The multimodal potential of WS to improve strength and vitality, arrest degeneration, and restore health through immunomodulation is its core strength.

The understanding of the pathophysiology of COVID-19 and its pre dominant affliction of lungs prior to multi-organ failure and systemic abnormalities that often precede death isimportant to understand while setting prevention and treatment targets. WS has been demonstrated to have several beneficial pulmonary effects- reducing pulmonary hypertension though reduction in inflammation, oxidative stress, endothelial dysfunction , apoptosis of pulmonary cells, and pulmonary airway resistance. WS was shown to improve the innate immune response and selectively up regulate Th1 cellular immune response. The anti-viral properties of the phyto-constituents of WS were recently shown in computational studies. An aqueous extract of WS was also shown to inhibit angiotensin converting enzyme which is now emerging as potential therapeutic target to treat COVID-19.

Health Condition / Problems Studied

Participants of either sex, 20 to 69 years of age

Participants tested negative for COVID-19 by nose and throat swab using RT PCR technique

HCQ naïve participants

Willing to come for regular follow – up visits

Written Informed Consent