Emerging trends from COVID-19 research registered in the Clinical Trials Registry - India

Rao, M. Vishnu Vardhana; Juneja, Atul; Maulik, Mohua; Adhikari, Tulsi; Sharma, Saurabh; Gupta, Jyotsna; Panchal, Yashmin; Yadav, Neha

doi:10.4103/ijmr.ijmr_2556_20

Cited by 18 publications

(6 citation statements)

References 45 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Similar higher figures (55.3%) for AYUSH-related trials were also reported by Bandyopadhyay et al [19]. Rao et al mentioned that 67 out of 122 studied trials were from the traditional system of medicine [21]. However, these studies were conducted in the very early stage of the pandemic in the year 2020.…”

Section: Discussionsupporting

confidence: 70%

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

Dutta,

Singhal,

Shah

2024

Cureus

View full text Add to dashboard Cite

Background: The Clinical Trials Registry -India (CTRI) database is a registry of various trials conducted in India and this study scrutinized the studies registered for COVID-19 from the database to detect patterns in trial design, appraising the target regions of therapies and comprehending the terrain of research endeavors.Method: This was a cross-sectional study that analyzed the registered trials for COVID-19 between March 2020 and September 2023. A trial search was conducted on the CTRI database to include all types of studies registered for COVID-19 with keywords like "COVID" and "coronavirus" and studies conducted on conditions other than COVID-19 were excluded. The data regarding study characteristics were noted under various sections in a preformed proforma.Results: A total of 807 trials were taken for final analysis and there were about 344 prospective and 260 retrospective interventional trials, 35 prospective and 165 retrospective observational studies, and two prospective and one retrospective post-marketing surveillance study. The majority of the studies had duration under 12 months (91%). The maximum number of studies were registered from AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) and allied therapies (n = 283), with about 104 types of interventions, followed by the drug category having 119 trials registered and about 57 types of interventions. Kabasura Kudineer and yoga in the AYUSH category, molnupiravir, colchicine, and favipiravir in the drug category, and tocilizumab and convalescent plasma among biologics were some common interventions used. The majority of trials did not mention the trial phase and declared it as not applicable (54%), whereas 15% were registered as phase 2 and 13% as phase 3. About 54% of the studies were randomized and randomized parallel-group design (20%) was the most common study design. Only 6% of the trials were post-graduate thesis and the majority of the trials (n = 535) denied sharing their individual participant data. Only 0.86% and 0.61% of the trials were terminated and suspended, respectively, denoting proper design and conduct of the trials. Conclusion:In the CTRI database, the majority of trials were prospective interventional studies, with a predominance of AYUSH therapies and drug interventions. Common interventions included Kabasura Kudineer and yoga in AYUSH, and molnupiravir, colchicine, and favipiravir in drugs. Most studies had durations under 12 months and randomized parallel-group design was the most common study design. The intention to use and promote an indigenous system of medicine looks promising in the absence of any definite therapy. A minute number of registered suspended and terminated trials might be a positive picture of meticulously designed and executed trials even during a pandemic situation in India.

show abstract

Section: Discussionsupporting

confidence: 70%

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

Dutta,

Singhal,

Shah

2024

Cureus

View full text Add to dashboard Cite

show abstract

“…Among the traditional medicine category, 31 trials were prophylactic and 36 were therapeutic, mostly conducted on asymptomatic or mild to moderate COVID-19 patients. 39 …”

Section: Discussionmentioning

confidence: 99%

“…were therapeutic, mostly conducted on asymptomatic or mild to moderate COVID-19 patients. 39 Countries with minimal resources need to implement appropriate mental and physical health prevention measures. Strategies, such as a psychological helpline, may be adopted to facilitate citizens seeking mental health advice and can easily maintain communication for required timely assistance.…”

Section: Discussionmentioning

confidence: 99%

Psychological trauma and depression in recovered COVID-19 patients: a telecommunication based observational study

Bandinelli¹,

Schäfer²,

Kluwe-Schiavon³

et al. 2023

Trends Psychiatry Psychother

View full text Add to dashboard Cite

Introduction Coronavirus disease 2019 (COVID-19) is adversely affecting the mental health of patients infected with the virus and the psychological impact on recovered COVID-19 patients is unclear. Objectives The study aimed to assess posttraumatic stress disorder (PTSD) and depression among COVID-19 patients after recovery from the disease. Methods This cross-sectional study was conducted from November 9, 2020, to December 23, 2020. The study used a telemedicine model to enroll recovered COVID-19 patients from a database of patients provided by the health authorities. The National Stressful Events Survey PTSD Short Scale (NSESSS) for adults was used to assess PTSD symptoms and the Patient Health Questionnaire (PHQ-9) was used to assess depression. Results The study enrolled 503 recovered COVID-19 patients with a mean age of 41.90 years. The majority were asymptomatic (64.6%), while 21.5% had had moderate to severe forms of the disease. Prevalence rates of PTSD symptoms and depression were 56.9 and 29% respectively. COVID-19 patients with severe forms of the disease were significantly more affected by PTSD symptoms (vs. mild, odds ratio [OR] = 18.7, 95%confidence interval [CI] 9.9-35.5) and depression (vs. mild, OR = 19.8, 95% CI 9.9-39.5). Similarly, patients who required oxygen or ventilator support reported significantly higher rates of PTSD symptoms (vs. managed at home, OR = 17.4, 95% CI 8.3-36.4) and depression (vs. managed at home, OR = 22.0, 95% CI 10.1-47.7). Conclusion This study reports that recovered COVID-19 patients suffered from a significant amount of depression and experienced significant PTSD symptoms. It will help with addressing a major psychological concern among the recovered subjects.

show abstract

“…Several Ayurvedic drug trials in COVID-19 were registered during the pandemic and the results of few published studies were encouraging [55,56]. A uniform wholesome Ayurvedic regimen showed a reduction in the viral load in asymptomatic and early COVID-19 patients in a randomized placebo-controlled drug trial study but did not provide sufficient clinical data [57].…”

Section: Other Selected Studiesmentioning

confidence: 99%

Co-administration of AYUSH 64 as an adjunct to standard of care in mild and moderate COVID-19: A randomized, controlled, multicentric clinical trial

Chopra¹,

Tillu

Choudhary

et al. 2023

PLoS ONE

View full text Add to dashboard Cite

Objective Evaluate the efficacy of AYUSH 64, a standard polyherbal Ayurvedic drug in COVID-19. Methods During the first pandemic wave, 140 consenting and eligible hospitalized adult participants with mild-moderate symptomatic disease (specific standard RT-PCR assay positive) were selected as per a convenience sample, and randomized (1:1 ratio) to an open-label (assessor blind) two-arm multicentric drug trial; standard of care (SOC as per Indian guidelines) versus AYUSH 64 combined with SOC (AYUSH plus). Participants were assessed daily and discharged once clinical recovery (CR, primary efficacy) was achieved which was based on a predetermined set of criteria (resolution of symptoms, normal peripheral oximetry, and negative specific RT-PCR assay). Each participant was followed using an indigenous software program(mobile phone) and completed a 12-week study period. The dose of AYUSH 64 was 2 tablets oral, 500 mg each, bid for 12 weeks (AYUSH plus only). Significant P was <0.05 (two-sided). On randomization, the groups were found well matched. Results The mean interval time from randomization to CR was significantly superior in the AYUSH plus group [mean 6.45 days versus 8.26 days, 95% Confidence Interval of the difference -3.02 to -0.59 (P = 0.003, Student’s ‘t test] as per-protocol analysis (134 participants); significant (P = 0.002) on an intention to treat analysis. 70% of the participants in AYUSH plus recovered during the first week (P = 0.046, Chi-square) and showed a significantly better change in physical health, fatigue, and quality of life measures. 48 adverse events, mostly mild and gut related, were reported by each group. There were 20 patient withdrawals (8 in AYUSH plus) but none due to an AE. There were no deaths. Daily assessment (hospitalization) and supervised drug intake ensured robust efficacy data. The open-label design was a concern (study outcome). Conclusions AYUSH 64 in combination with SOC hastened recovery, reduced hospitalization, and improved health in COVID-19. It was considered safe and well-tolerated. Further clinical validation (Phase III) is required. Trial registration CTRI/2020/06/025557.

show abstract

Emerging trends from COVID-19 research registered in the Clinical Trials Registry - India

Cited by 18 publications

References 45 publications

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

A Systematic Analysis of COVID-19 Clinical Trials Registered in the Clinical Trials Registry of India

Psychological trauma and depression in recovered COVID-19 patients: a telecommunication based observational study

Co-administration of AYUSH 64 as an adjunct to standard of care in mild and moderate COVID-19: A randomized, controlled, multicentric clinical trial

Contact Info

Product

Resources

About