Evidence map›Paper›PMID 42694770›Full record

Trial reportFrontiers in medicine2026

Safe prolonged prophylactic use and tolerability of Ashwagandha following COVISHIELD™ vaccination over 24 weeks: a multicentre randomized double-blind placebo-controlled trial.

Arvind Chopra, Susmita Chaudhuri, Manohar S Gundeti, S Sarmukaddam, Girish Tillu, Preeti Chavan-Gautam, Shruti Khanduri, Sophia Jameela, Azeem Ahmad, Amit Kumar Rai and 35 more

Abstract readClinical Trial
In one paragraph

Trial report in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

45 authors.

Arvind ChopraCentre for Rheumatic Diseases, Pune, India.
Susmita ChaudhuriTranslational Health Science and Technology Institute (THSTI), Faridabad, Haryana, India.
Manohar S GundetiCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
S SarmukaddamCentre for Rheumatic Diseases, Pune, India.
Girish TilluAYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
Preeti Chavan-GautamAYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
Shruti KhanduriCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Sophia JameelaCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Azeem AhmadCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Amit Kumar RaiCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Prasanna N RaoSri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
Sarvesh Kumar SinghNational Institute of Ayurveda, Jaipur, India.
Santosh Y MudakappagolKLE SBMK Ayurveda Mahavidyalaya, Belagavi, Shahapur, Karnataka, India.
Govind ReddyCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Tanuja NesariAll India Institute of Ayurveda, Sarita Vihar, New Delhi, India.
Dilip GodeDMIHER(DU) Sawangi (Meghe), Wardha, India.
K Rajeshwar ReddyR. A. Podar Medical College (Ayu), Mumbai, India.
Manjit SalujaCentre for Rheumatic Diseases, Pune, India.
Sanjay TamoliTarget Institute of Medical Education and Research, Mumbai, India.
Dattatray DigheCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
B C RavikumarSri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
B G VittalSri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
Shailaja USri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
RakeshSri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
M S SeetharamuSri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
Kshipra RajoriaNational Institute of Ayurveda, Jaipur, India.
Giridhar VedantamKLE SBMK Ayurveda Mahavidyalaya, Belagavi, Shahapur, Karnataka, India.
Shashikant DudhgaonkarAYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
Rasika KolheCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Swapnil BorseAYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
U R Sekhar NamburiCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Manish P DeshmukhDMIHER(DU) Sawangi (Meghe), Wardha, India.
Priyanka BangreDMIHER(DU) Sawangi (Meghe), Wardha, India.
Anand MoreAll India Institute of Ayurveda, Sarita Vihar, New Delhi, India.
S RajgopalaAll India Institute of Ayurveda, Sarita Vihar, New Delhi, India.
Raju SinghAll India Institute of Ayurveda, Sarita Vihar, New Delhi, India.
Shalini RaiAll India Institute of Ayurveda, Sarita Vihar, New Delhi, India.
Sandeep Singh TiwariAll India Institute of Ayurveda, Sarita Vihar, New Delhi, India.
Sanket JainCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Amrish P DedgeCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Babita YadavCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Bcs RaoCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
N SrikanthCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
R N AcharyaCentral Council for Research in Ayurvedic Sciences, New Delhi, India.
Bhushan PatwardhanAYUSH Center of Excellence, Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Ashwagandha ( Methods: 1,200 consenting apparently healthy participants (age 18-70 years) with a negative SARS-CoV-2 RNA assay (RT-PCR using oral and nasal swab) were randomized within 7 days of vaccine administration (primary or booster) to receive oral standardized Ashwagandha (500 mg aqueous root extract) or a matching placebo daily. Participants were monitored every 4 weeks till weeks 28 (study completion) which included comprehensive clinical and laboratory assessment, specific viral RNA and IgG antibody assays (including Wuhan and Delta strain neutralization). Statistical analyses were performed using standard methods, with a two-sided Results: Of the 1,200 randomized participants, 122 (10.2%) were assigned to the SDG (Single Dose Group), 503 (41.9%) to the DDG (Double Dose Group), and 575 (47.9%) to the BDG (Booster Dose Group); overall, 1,032 participants (86%) completed the trial. The safety and tolerability profile of Ashwagandha was comparable to placebo. Adverse events were predominantly gut related and mild, and none caused withdrawal. Following first Covishield™ injection, a persistently higher IgG antibody assay was observed in the Ashwagandha arm (not statistically significant). The cumulative incidence rate of breakthrough infections was 3.9% (95% confidence interval 3.0-5.2%) and did not differ by study intervention. The immunogenic effect of Ashwagandha could not be demonstrated, likely due to a persistently high post-vaccination immune response. In addition, approximately 70% of participants were seropositive for nucleocapsid antibodies at baseline, indicating prior SARS-CoV-2 infection. Conclusion: Prolonged use and tolerability of Ashwagandha in post-vaccinated healthy participants was shown safe but adjunct immunogenicity could not be discerned. Further research is required. Clinical Trial Registration: http://www.clinicaltrials.gov/, identifier CTRI/2021/06/034496.

Indexed as

AyurvedaCOVID-19 vaccineherbal medicineimmunogenicitysafetywithaniasomnifera

Identifiers

PMID42694770
PMCPMC13539556

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.