key: cord-0792802-y2ncjzyy
authors: Bhapkar, Vedvati; Bhalerao, Supriya
title: Portrayal of status of AYUSH clinical studies for COVID-19: A CTRI perspective
date: 2021-06-15
journal: J Ayurveda Integr Med
DOI: 10.1016/j.jaim.2021.05.013
sha: e1f620bd74c1e2b9c2b769d24612c25ec884c7d7
doc_id: 792802
cord_uid: y2ncjzyy

nan

Dear Editor, This is further to our manuscript entitled, 'A critical analysis of CTRI registered AYUSH studies for COVID-19', which is accepted for publication in your esteemed journal as a part of COVID-19 special collection. 1 In this study, we have analyzed different characteristics of 197 AYUSH clinical studies for COVID-19 registered in CTRI from 1 st February 2020 to 24 th August 2020. We have expressed a very optimistic view at the end of the manuscript that the number of AYUSH studies registered with CTRI definitely indicates a progressive change towards evidence-based medicine. Hence, we recently tried to explore the evidence generated through these huge number of studies.

During our initial analysis, we had noticed that many of the registered studies (n=177) were of duration of six months or less. It was therefore assumed that the studies would have been completed and in publication stage by now. However, when we revisited the CTRI on 15 th April 2021, we noticed that even after six months (perhaps more than that), majority i.e.,111 of 197 studies stated their status as 'Not yet recruiting'. Fifty-eight studies showed status as 'Completed' or 'Closed recruitment' and 28 studies had status as 'Open to recruitment'. Only one study mentioned the study status as 'Suspended'. Of the 58 studies which were 'Completed' or 'Closed recruitment', only 13 studies had mentioned a completion date and 10 studies had updated publication status along with it. Out of these 10 studies, 6 studies mentioned that their publications were under process and only 4 studies actually provided the publication details. Interestingly only 2 of these 4 studies are published in PubMed and Scopus indexed journals. For the rest 35 studies, no details regarding completion date and publication status could be obtained. It is possible that the status in CTRI has not been updated by the investigators.

On the other hand, we also reviewed the articles available at COVID-19 special collection of Journal of Ayurveda & Integrative Medicine. 2 We observed that of the 26 articles, 17 are review articles focussed on the review of its pathophysiology, symptomology, treatments etc. Only 9 articles present clinical trials, case studies or case reports. Though understanding of COVID-19 from Ayurveda perspective is essential, what we need now is the outcomes of the clinical trials initiated almost a year back, which would prove helpful to fight with the second wave.

For our article mentioned above, we had analyzed AYUSH clinical studies registered in CTRI till 24 th August 2020. A quick glance of the studies registered later reveals that another 118 AYUSH studies have been registered in CTRI till 15 th April 2021. 3 It would have been ideal to review the publications emerged out of past studies before commencing new studies. This would have helped to improve research methodology and scientific rigor in the newer studies.

A critical aspect of any clinical study is dissemination of its results. Unfortunately, a dearth of credible Indian publications for COVID-19 management is seen from the initial days of this pandemic. Odone et al, 4 in their analysis of first 10,000 papers on COVID-19 have raised the issue of predominance of 'concern' over 'data' in publications. This analysis also highlights a bitter truth that India, which was in first-five countries with highest disease burden, did not feature anywhere in the publication list. The condition of AYUSH publications is further dismal.

To publish the results of clinical studies (irrespective of outcome) is an ethical responsibility of the researchers/investigators. In addition, the COVID-19 pandemic has taught us importance of swiftness and vigilance. We believe we should integrate this lesson in the dissemination of our research findings too. Thus, through this letter we wish to sincerely appeal to the investigators of AYUSH studies registered with CTRI to update their study status and publication details in CTRI, though not mandatory. This will be real contribution to the science and the battle against COVID-19.

A critical analysis of CTRI registered AYUSH studies for COVID-19

COVID-19 collection

University Vita-Salute San Raffaele COVID-19 literature monitoring working group. The first 10 000 COVID-19 papers in perspective: are we publishing what we should be publishing?