Indian Council Of Medical Research Research Articles

Analysis of informed consent documents for compliance with ICMR guidelines for biomedical and health research

Abstract Background: Ethical conduct of research depends on the voluntary expression of consent and adequate disclosure of information about the research in informed consent documents (ICDs). Objectives: The objective of this study was to analyze ICDs of academic studies for compliance with National Ethical Guidelines for Biomedical and Health Research laid down by the Indian Council of Medical Research (ICMR) and to determine the readability of ICDs using the Flesch–Kincaid Grade Level scale and Flesch reading-ease (FRE) score. Methodology: ICDs of academic research projects submitted during 2020–22 were retrieved from the IEC office and analyzed for compliance with ICMR 2017 guidelines. The readability of the documents was assessed by the Flesch–Kincaid Grade Level Scale and FRE score. Results: Among 177 protocols analyzed, the most common were epidemiological studies (36.72%), followed by diagnostic studies (28.81%). Vernacular translations of ICDs were present in significantly more studies in 2022 (χ 2 = 7.18, P = 0.02) as compared to 2020 and 2021. FREs score was 45.75 ± 10.76, and Flesch–Kincaid Grade Level was 8.67 ± 1.44. Content analysis of participant information sheet (PIS) revealed that significantly more PIS submitted in 2022 mentioned expected duration of participation (χ 2 = 6.95, P < 0.001), benefit to patient/community (χ 2 = 26.63, P < 0.001), disclosure of foreseeable risk or discomfort (χ 2 = 21.72, P < 0.001), payment for participation (χ 2 = 21.72, P < 0.001), and identity of research team and contact details (χ 2 = 18.58, P < 0.001). Compliance score was significantly better in 2022 as compared to 2020 and 2021. Conclusion: Gradually, ICDs became more compliant with ICMR guidelines. Still, there is scope for improvement in ICDs regarding content and readability so that patients can comprehend facts easily to make informed decisions in a real sense.

The Indian Multiple Sclerosis And Allied Demyelinating Disorders Registry And Research Network (IMSRN): Inception to Reality

BackgroundDemyelinating disorders of the CNS are a set of chronic, inflammatory, autoimmune conditions. To improve understanding of epidemiology, population characteristics and disease behaviour, an Indian, hospital-based registry has been established to serve as a platform for fostering collaborative research. The following article outlines the development, governance and current status of the Indian Multiple Sclerosis and Allied Demyelinating Disorders Registry and Research Network (IMSRN), the country's first scientific database and dedicated expert research network of these disorders. MethodsMultiple reviews and stakeholder meetings were held to set up the registry. The IMSRN was formally initiated in August 2021 across 26 tertiary care centres. The registry is governed by the Indian Council of Medical Research (ICMR), New Delhi and its task force committee. The online secure database captures detailed clinical and imaging patient details at baseline and periodic follow up. Periodic meetings of the task force and collaborators are held to discuss the progress, improvements and research proposals. ResultsThe IMSRN is currently active and recruiting patients following an informed consent. As of current, more than 3336 patients including RIS (N = 8), CIS (N = 134), MS (N = 1674), NMOSD (N= 561), MOGAD (N = 404), ADEM (N = 46), CRION (N = 21), CLIPPERS (N = 2), and GFAP (N =1) have been enrolled. 340 patients, not meeting the diagnostic criteria for any of the aforementioned disease phenotypes are in the others category. Various research proposals are being developed to study different aspects of these disorders. ConclusionThe IMSRN has been established with a vision to strengthen our understanding about MS NMOSD, MOGAD and other demyelinating disorders. This would help answer important questions related to disease profiles and long-term outcomes of patients in the Indian setting. From the standpoint of clinical practice, therapeutics, patient management, research, and national policy building, IMSRN shall serve as a synergising platform for bridging the gap in the aforementioned areas and guiding future research through national and international collaboration.

Effectiveness of video-assisted teaching on prevention of constipation among postpartum women admitted in postnatal ward at a tertiary care hospital: a randomised controlled trial

BackgroundThe postpartum period is a vital phase for a mother as she undergoes a role transition in her life, in addition to physiological changes. Among all discomforts experienced during this...

Comparison of seven commercial RT-PCR kits with the NIV kit for the diagnosis of Covid-19

Objectives Coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) spread across the globe in an unprecedented manner and was declared a pandemic on March 11, 2020 by the World Health Organization (WHO). This study was carried out with the aim to compare the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and agreement of the eight different RT-PCR kits for the diagnosis of COVID-19. Material and Methods This observational cross-sectional study was carried out in the Department of Microbiology of a tertiary care hospital in Central Delhi from July to October 2021. A total of 45 nasopharyngeal and/or oropharyngeal swabs in Viral Transport Medium (VTM) from suspected COVID-19 patients were received in the laboratory for RT-PCR. These samples were tested by eight different Indian Council of Medical Research (ICMR)-approved RT-PCR kits with different gene targets. The comparison was made with the National Institute of Virology (NIV), the Pune COVID-19 RT-PCR kit. Statistical analysis: sensitivity, specificity, PPV, and NPV were calculated for each kit and compared using the McNemar test. Agreement of different kits was evaluated using Kappa analysis. Results The results of the 45 samples of suspected COVID-19 cases were recorded as per the cycle threshold (Ct) provided in the kit insert. Of these, 15 samples detected both E and RdRp genes and 30 were negative for both the genes of SARS CoV-2 by NIV, the Pune COVID-19 RT-PCR kit. All kits showed 100% sensitivity and had 100% NPV when compared with the NIV kit. However, specificity, PPV, and agreement were variable as compared to the NIV kit. Conclusion The reporting should be carried out as per the manufacturer’s instructions. However, positive results with Ct values ≥ 36 showed variable results with different RT PCR kits and hence should be interpreted with caution.

Evaluation of risk factors associated with hard-to-heal wound infection in a tertiary care hospital.

The incidence of hard-to-heal wound infection, especially as a result of multidrug-resistant Gram-negative organisms, has increased in recent years. The reason for the increase is multifactorial and the ability of these pathogenic isolates to form biofilms is one of the important risk factors in wound infection. This study aimed to evaluate the risk factors associated with such cases. This prospective analytical study, conducted over a period of two months, included pus or tissue samples from hospital inpatients with Gram-negative hard-to-heal wound infection. The samples were processed with conventional microbiological techniques. Patient demographic details and the presence of various risk factors were recorded. Biofilm production was detected by tissue culture plate method in the laboratory. The data were analysed using SPSS version 21 (IBM Ltd., US). The experimental cohort comprised 200 patients. Klebsiella spp. was the most common identified organism, followed by Escherichia coli and Pseudomonas spp. Carbapenem resistance was observed in 106 (53%) strains. Almost 66% of the strains showed biofilm formation. On evaluation of associated risk factors, age (p=0.043), presence of biofilms (p=0.0001), diabetes (p=0.002), hypertension (p=0.02) and medical device use (p=0.008) had significant association, whereas sex, previous surgery and prior antibiotic use had no significant impact on the chronicity of the wound. In this study, chronicity of wounds was observed to be associated with multiple risk factors, especially the biofilm-forming ability of the strain. Biofilms are difficult to eradicate and additional measures, such as physical debridement, are important for resolving chronicity. Knowledge about specific risk factors would also allow clinicians a better understanding of the healing process and drive appropriate wound care interventions. A grant was received from the Indian Council of Medical Research (ICMR) for this work (grant ID: 2017-02686). The authors have no conflicts of interest to declare.

Approach towards surveillance-based diagnosis of acute respiratory illness in India: Expert recommendations

BackgroundEmerging infectious diseases, often zoonotic, demand a collaborative “One-Health” surveillance approach due to human activities. The need for standardized diagnostic and surveillance algorithms is emphasized to address the difficulty in clinical differentiation and curb antimicrobial resistance. ObjectiveThe present recommendations are comprehensive diagnostic and surveillance algorithm for ARIs, developed by the Indian Council of Medical Research (ICMR), which aims to enhance early detection and treatment with improved surveillance. This algorithm shall be serving as a blueprint for respiratory infections landscape in the country and early detection of surge of respiratory infections in the country. ContentThe ICMR has risen up to the threat of emerging and re-emerging infections. Here, we seek to recommend a structured approach for diagnosing respiratory illnesses. The recommendations emphasize the significance of prioritizing respiratory pathogens based on factors such as the frequency of occurrence (seasonal or geographical), disease severity, ease of diagnosis and public health importance. The proposed surveillance-based diagnostic algorithm for ARI relies on a combination of gold-standard conventional methods, innovative serological and molecular techniques, as well as radiological approaches, which collectively contribute to the detection of various causative agents.The diagnostic part of the integrated algorithm can be dealt at the local microbiology laboratory of the healthcare facility with the few positive and negative specimens shipped to linked viral disease research laboratories (VRDLs) and other ICMR designated laboratories for genome characterisation, cluster identification and identification of novel agents.

Family and facility care variables attributing to postnatal depression among women in two tribal-dominated districts of Odisha: Log model analysis to suggest intervention

ABSTRACT Introduction: It is a proven fact that women are affected by poor mental health predominantly in the postnatal period. This is authenticated by the use of a validated and tested Edinburg Postnatal Depression scale (EPNS), which is a simple tool to measure depression among women after delivery by posing 10 questions and this is also validated in Odia language. Odisha has made laudable progress in delivering Maternal and Child Health care to women even in tribal-dominated districts through its robust Comprehensive Obstetrics care network restricting home delivery almost to a mere 4%–5% and reducing maternal deaths by 60%–70% as per the National Family Health Survey (NFHS-5). As a part of an Indian Council of Medical Research (ICMR) extramural project to enhance contraceptive acceptance among males in districts that had a total fertility rate (TFR) higher than 3, a qualitative objective to measure mean postnatal depression in the early postpartum period (who are also the target to advocate contraceptive acceptance) was undertaken. A secondary objective was to compare family care vs. facility care as greater attributing factors for higher EPNS scores. Materials and Methods: Due to time constraints, the study was done on a fast-track mode wherein two villages each from the sampled blocks of Koraput and Boudh (with one of the highest birth rates) were selected. All women in villages who had a baby aged between 1 and 6 months, were the sampling frame and only those were selected who consented. A questionnaire was used that elicited information on familial sociodemographic details and also facility-based antenatal care (ANC) and postdelivery services that were availed for the last-born child. General Health Questionnaire-12 (GHQ-12) scores were used as an independent variable and a proxy measure of cumulative familial stress. Descriptives and log regression were used to measure the odds of family vs. facility-based services. Results: A total of 98 women, 50 from Boudh and 48 from Koraput, participated in the study. Koraput’s mean EPNS scores were 6 points higher than Boudh indicating much higher postnatal poor mental health. Log models showed that there was no difference between facility-based care in both districts as both reported 96%–97.3% institutional delivery, with out-of-pocket expenditure (OOP) being less than 520 Indian rupees on average and nearly 100% reported receipt of iron folic acid and calcium as well as streamlined Janani Suraksha Yojana (JSY) services. However, the odds of men’s participation in Family planning was 2.77 times less in Koraput (SD = 2.582), fourth birth order 1.33 odds, and female gender 5.66 odds higher for the district as a result of which GHQ 12 score mean was 21.00 (CI: 19.18–22.82) hinting very high psychological stress as compared with Boudh where the mean was 17 (CI: 14.59–19.41). Conclusion: This clearly indicates that a robust healthcare delivery alone will not be able to address the holistic health of women in the childbearing age group. Familial stressors compound poor mental health and hence counseling of the family as a whole is necessary to achieve sound mental health in women in the postnatal period. The spousal role is emerging as a strong determinant, especially in terms of nonacceptance or casual approach to contraceptive use. Interestingly, a skewed gender bias is noted for the female child, which is also a contributor to postnatal depression (PND) in both districts, though a bigger sample would be needed to statistically prove it.

Analyzing Breakthrough Infections in a Tertiary Care Hospital: A Retrospective Study Utilizing RAT-Based Screening

Prompt diagnosis of coronavirus disease 2019 (COVID-19) is requisite due to the upsurge of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) cases globally. Real-time reverse-transcription polymerase chain reaction (rRT-PCR) remains as the gold standard for the diagnosis of SARS-CoV-2 due to its higher sensitivity and specificity. Regardless, due to its longer turnaround time and expertise, bed side testing rapid antigen based tests were developed in order for portable, rapid diagnosis of the disease. The present study delineates the utility of Rapid Antigen Testing (RAT) screening among symptomatic and asymptomatic patients in a tertiary care hospital. This is a retrospective data collection study from Indian Council of Medical Research (ICMR) portal by exporting the excel sheet from March 2021 to March 2022 who undergone COVID testing in a tertiary care diagnostics facility. The demographic and vaccination details of the individuals were extracted using ICMR Sample referral form (SRF) from all patients who are tested for RAT. Of the total 9898 patients tested for RAT, 392 and 9506 were vaccinated and unvaccinated, respectively. Among them, number of positives was 3% and 15% respectively. The odds ratio showed that the vaccinated individuals had 81.4% reduced risk of getting infection compared to unvaccinated individuals (OR-0.186; p=0.001). A significant difference was observed between the type of vaccine used and COVID infection, majority of them had taken Covishield (83.5%) followed by Covaxin (16%) [p=0.0005]. Males showed a marginally significant p trend with COVID infectivity (OR=1.114, p=0.073) too. RAT is useful as a screening test for rapid diagnosis of infection in patients who are more prone to spread the disease. As RAT is cost effective and had short-turnaround time, it can be recommended in areas with upsurge in SARS-CoV-2 cases to administer isolation and infection control measures.

A critical review of Pathya Apathya in Dyslipidemia

According to Ayurveda, dyslipidemia and Medoroga are connected. Medoroga is a disease brought on by Medovridhi, which in turn prevents other Dhatus from receiving enough food. The major cause of the linked conditions Medoroga, Prameha, and Sthaulya is a vitiated Medo Dhatu. Thus, the management of these disorders is likewise comparable. Rukshana, Udvartana, Ruksha-Ushna Basti, Virechana, and Shamana Prayogas like Guggulu, Shilajithu, Guduchi, etc. are all used in Ayurvedic medicine to treat Medoroga. A condition of lipoprotein metabolism known as dyslipidemia can cause either an excess or a shortage of lipoproteins, or perhaps both. Atherosclerosis is a result of elevated amounts of atherogenic lipoproteins, mostly LDL but also IDL. This may then result in peripheral vascular disease (PVD), cerebral vascular disease (CVD), coronary artery disease (CAD), etc. According to the Indian Council of Medical Research (ICMR) monitoring study, dyslipidemia is more common in young male industrial workers (62%) than it is in adults between the ages of 15 and 64. Dyslipidemia goes unnoticed and untreated until a problem, such as a myocardial infarction brought on by early atherosclerosis, occurs.

A cross-sectional observational study for ethno-geographical disparities in sleep quality, brain morphometry and cognition (a SOLACE study) in Indians residing in India, and South Asians and Europeans residing in the UK - a study protocol.

As individuals age, their sleep patterns change, and sleep disturbances can increase the risk of dementia. Poor sleep quality can be a risk factor for mild cognitive impairment (MCI) and dementia. Epidemiological studies show a connection between sleep quality and cognitive changes, with brain imaging revealing grey matter volume reduction and amyloid beta accumulation in Alzheimer's disease. However, most research has focused on Europeans, with little attention to other ethnic groups. This is a cross sectional study comparing effects across countries and ethnicities. Group 1 (n = 193) will be Indians residing in India (new participant recruitment), Group 2 will be South Asians residing in UK and group 3 will be Europeans residing in the UK. For group 2 and 3 (n = 193), data already collected by UK-based Southall and Brent REvisited (SABRE) tri-ethnic study will be used. For group 1, Pittsburgh Sleep Quality Index questionnaire (PSQI) will be used for assessment of sleep quality, Indian Council of Medical Research (Neurocognitive ToolBox) (ICMR-NCTB) for cognition testing and a 3 T MRI cerebral scan for brain morphometry. The data will be compared to sleep, cognitive function and brain MRI parameters from SABRE. Racial and ethnic differences can impact the relationships of cognitive function, sleep quality and brain structure in older adults. Earlier studies have highlighted higher prevalence of poor sleep among black individuals compared to white individuals. Genetic or epigenetic mechanisms may contribute to these variations. Socio-cultural and environmental factors, such as neighbourhood, migration, lifestyle, stress and perceived discrimination may influence sleep patterns. The aim of the study is to examine the ethnogeographic variations in sleep quality, cognitive performance and brain morphometry among Indians living in India, and South Asians and Europeans residing in the UK.

Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study.

Fungal infections are now a great public health threat, especially in those with underlying risk factors such as neutropenia, diabetes, high-dose steroid treatment, cancer chemotherapy, prolonged intensive care unit stay, and so on, which can lead to mycoses with higher mortality rates. The rates of these infections have been steadily increasing over the past 2 decades due to the increasing population of patients who are immunocompromised. However, the data regarding the exact burden of such infection are still not available from India. Therefore, this registry was initiated to collate systematic data on invasive fungal infections (IFIs) across the country. The primary aim of this study is to create a multicenter digital clinical registry and monitor trends of IFIs and emerging fungal diseases, as well as early signals of any potential fungal outbreak in any region. The registry will also capture information on the antifungal resistance patterns and the contribution of fungal infections on overall morbidity and inpatient mortality across various conditions. This multicenter, prospective, noninterventional observational study will be conducted by the Indian Council of Medical Research through a web-based data collection method from 8 Advanced Mycology Diagnostic and Research Centers across the country. Data on age, gender, clinical signs and symptoms, date of admission, date of discharge or death, diagnostic tests performed, identified pathogen details, antifungal susceptibility testing, outcome, and so on will be obtained from hospital records. Descriptive and multivariate statistical methods will be applied to investigate clinical manifestations, risk variables, and treatment outcomes. These Advanced Mycology Diagnostic and Research Centers are expected to find the hidden cases of fungal infections in the intensive care unit setting. The study will facilitate the enhancement of the precision of fungal infection diagnosis and prompt treatment modalities in response to antifungal drug sensitivity tests. This registry will improve our understanding of IFIs, support evidence-based clinical decision-making ability, and encourage public health policies and actions. Fungal diseases are a neglected public health problem. Fewer diagnostic facilities, scanty published data, and increased vulnerable patient groups make the situation worse. This is the first systematic clinical registry of IFIs in India. Data generated from this registry will increase our understanding related to the diagnosis, treatment, and prevention of fungal diseases in India by addressing pertinent gaps in mycology. This initiative will ensure a visible impact on public health in the country. DERR1-10.2196/54672.

An integrated FoodNet in North East India: fostering one health approach to fortify public health

BackgroundFood safety is a critical factor in promoting public health and nutrition, especially in developing countries like India, which experience several foodborne disease outbreaks, often with multidrug-resistant pathogens. Therefore, implementing regular surveillance of enteric pathogens in the human-animal-environment interface is necessary to reduce the disease burden in the country.ObjectiveTo establish a network of laboratories for the identification of major food and waterborne pathogens prevailing in the northeast region of India through integrated surveillance of animal, food, human, and environment and investigate the antimicrobial susceptibility pattern of the pathogens of public health significance.MethodsThe Indian Council of Medical Research (ICMR) has identified FoodNet laboratories; based on their geographical location, inclination to undertake the study, preparedness, proficiency, and adherence to quality assurance procedures, through an 8-step process to systematically expand to cover the Northeastern Region (NER) with comprehensive diagnostic capacities for foodborne pathogens and diarrhea outbreak investigations. Network initiated in the NER given the unique food habits of the ethnic population.FindingsThis surveillance network for foodborne enteric pathogens was established in Assam, Arunachal Pradesh, Tripura, and Sikkim, and expanded to other four states, i.e., Manipur, Mizoram, Meghalaya, and Nagaland, thereby covering the entire NER by including nine medical and three veterinary centers. All these centers are strengthened with periodic training, technical support, funding, capacity building, quality assurance, monitoring, centralized digital data management, and website development.ResultsThe ICMR-FoodNet will generate NER-specific data with close to real-time reporting of foodborne disease and outbreaks, and facilitate the updating of food safety management protocols, policy reforms, and public health outbreak response. During 2020-2023, 13,981 food samples were tested and the detection of enteric pathogens ranged from 3 to 4%. In clinical samples, the detection rate of the pathogens was high in the diarrheal stools (8.9%) when 3,107 samples were tested. Thirteen outbreaks were investigated during the study period.ConclusionFoodborne diseases and outbreaks are a neglected subject. Given the frequent outbreaks leading to the deaths of children, it is crucial to generate robust data through well-established surveillance networks so that a strong food safety policy can be developed for better public health.

Heart & Homoeopathy In COVID 19

Recently, the Indian Council of Medical Research (ICMR) through studies confirmed that there is no link between the COVID-19 vaccines & heart issues. The larger issue is that there is an established link between COVID-19 disease & heart issues. The current article deals with the details of the process of COVID-19 & heart problems. The patho-physiology, symptoms pattern, epidemiology of the entire phenomenon is touched upon. To deal with the COVID related heart issues, the article proposes the integration of Homoeopathy of AYUSH. In the article, it details out a suggested treatment protocol based on homoeopathic therapeutics for COVID related heart issues. Taking into account the risk factors involved in these heart issues, the percentage of individuals who have high blood sugar & high blood pressure levels in India are considered at high risk. The related data from National Family Health Survey 5th round is cited to enumerate the risk involved at the national level. Finally, the article banks on the useful properties of homoeopathy. These are cost effectiveness, clinical effectiveness & zero side effects. The article also enumerates its role in the mass coverage at the national level.

The Cancer Mukt Jagrukta Abhiyan-Arunachal Pradesh

The Cancer Mukt Jagrukta Abhiyan-Arunachal Pradesh is a joint project by Government of Arunachal Pradesh, Mon Indigenous Culture & Welfare Society, Chabbi Sahayog Foundation and Dev Desh Vaidyakiya Shaikshanik Samajik Pratishthan with the aim to create awareness about cancer prevention, early detection, and treatment among the residents of Arunachal Pradesh. The project will involve conducting awareness campaigns, providing training and education to healthcare professionals, and establishing cancer screening and treatment center's in the state. Cancer incidence and its related mortality has been a public health concern for Arunachal Pradesh in India. However, there is a lack of evidence about the knowledge, attitude and practice (KAP) for cancer risk factors, screening programme and preventive behavior – especially among indigenous tribal populations. A health camp based survey was conducted from 21st November 2023 to 28th November 2023 among an indigenous population of Tawang District Arunachal Pradesh. Snowball sampling was used to enroll 705 participants (233 were male and 472 were female). Univariate and bivariate analyses were conducted using SPSS version 23 to test the hypothesis of KAP. (There is no difference in the level of knowledge / in the attitude / level of practice among study participants with respect to any independent (socio-demographic and other) factors.) The Papumpare Cancer Registry reported the highest cancer density among women and the second highest among men among all population-based cancer registries in India (Indian Council of Medical Research, Report of National Cancer Registry Programme, Bengaluru, India 2020). Knowledge about the cause of cancer and risk factors was poor among the respondents. Attitude towards screening was negative . Practice levels to prevent cancer were also low. More than 50% of the cases were treated outside the state and at private hospitals. Knowledge about cancer symptoms and risk factors was limited in the population. There is a need for more effective health promotion services in the state. Mass screening facilities and behavioral change activities are required and could be disseminated through social media platforms. Our analysis of a north-eastern region of India, which has unique geographical and cultural characteristics, informs future policy designs and other related studies for controlling cancer in the area

Tracing the COVID-19 spread pattern in India through a GIS-based spatio-temporal analysis of interconnected clusters

Spatiotemporal analysis is a critical tool for understanding COVID-19 spread. This study examines the pattern of spatial distribution of COVID-19 cases across India, based on data provided by the Indian Council of Medical Research (ICMR). The research investigates temporal patterns during the first, second, and third waves in India for an informed policy response in case of any present or future pandemics. Given the colossal size of the dataset encompassing the entire nation’s data during the pandemic, a time-bound convenience sampling approach was employed. This approach was carefully designed to ensure a representative sample from advancing timeframes to observe time-based patterns in data. Data were captured from March 2020 to December 2022, with a 5-day interval considered for downloading the data. We employ robust spatial analysis techniques, including the Moran’s I index for spatial correlation assessment and the Getis Ord Gi* statistic for cluster identification. It was observed that positive COVID-19 cases in India showed a positive auto-correlation from May 2020 till December 2022. Moran’s I index values ranged from 0.11 to 0.39. It signifies a strong trend over the last 3 years with r^2 of 0.74 on order 3 polynomial regression. It is expected that high-risk zones can have a higher number of cases in future COVID-19 waves. Monthly clusters of positive cases were mapped through ArcGIS software. Through cluster maps, high-risk zones were identified namely Kerala, Maharashtra, New Delhi, Tamil Nadu, and Gujarat. The observation is: high-risk zones mostly fall near coastal areas and hotter climatic zones, contrary to the cold Himalayan region with Montanne climate zone. Our aggregate analysis of 3 years of COVID-19 cases suggests significant patterns of interconnectedness between the Indian Railway network, climatic zones, and geographical location with COVID-19 spread. This study thereby underscores the vital role of spatiotemporal analysis in predicting and managing future COVID-19 waves as well as future pandemics for an informed policy response.

A Study on SARS-CoV-2 Infection and Its Association with Co-morbidities: A Retrospective Cohort Study

Introduction: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a novel coronavirus (nCoV) that causes viral pneumonia known as Coronavirus Disease 2019 (COVID- 19). It can infect people of all age groups, and various clinical conditions are strong indicators of co-morbidities in COVID- 19. The presence of co-morbidities is crucial in determining the clinical outcome of coronavirus infections. Therefore, it is crucial to understand the demographic profile and associated risk factors of COVID-19 in this geographical region. Aim: To assess the association between SARS-CoV-2 infection and demographic characteristics and co-morbidities. Materials and Methods: A retrospective cohort study was conducted at the National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited Virology Service Laboratory (VSL) of Tripura Medical College and Dr. BR Ambedkar Memorial Teaching Hospital, Agartala, Tripura, India. All the required data was collected between May 2021 and October 2022, and data analysis was carried out from February to March 2023. After obtaining Indian Council of Medical Research (ICMR) approval, real-time Reverse Transcriptase-Polymerase Chain Reaction (rRT-PCR) was used for the detection of SARS-CoV-2 RNA. A total of 10,263 samples were included in the study. RNA extraction was performed using the viral Ribonucleic Acid (RNA) extraction Miniprep Kit protocol manufactured by MDI Membrane Technologies, and RT-PCR was conducted according to the Indian Council of Medical Research (ICMR)-approved DiAGSureTM nCoV-19 Detection Assay (Multiplex, TaqMan based) protocol developed by GCC BIOTECH. The findings were based on demographic parameters such as age group and gender distribution. Results were expressed as proportions and percentages, and statistical analysis was done by Chi-square test in Statistical Package for Social Sciences (SPSS) version 20.0. Results: Out of the 10,263 registered patients, 1471 (14.33%) were confirmed to have SARS-CoV-2 infection. The most affected age group was found to be between 21 and 40 years, with 524 (35.62%) cases. Males, 927 (63.02%) were more frequently infected than females, 544 (36.98%). Among all the SARS-CoV-2 infected patients, co-morbidities were found in 254 (17.26%) cases, and the association between co-morbidities and the rRT- PCR test results was found to be statistically significant, with a p-value=0.01. Conclusion: The highest number of SARS-CoV-2 patients were found in the age group of 21 to 40 years, predominantly among males. Patients with co-morbidities showed a significant association with SARS-CoV-2 infection. Diabetes was found to be the most prevalent risk factor among all the patients.

Capacity Building in Research on Traditional Medicine: Experience of a Workshop Conducted under the Aegis of the Indian Council of Medical Research

Training healthcare professionals in research methodology is essential to promote research and innovation. This is particularly relevant in India, where there is a wealth of potential drug candidates from Indian Traditional Medicine (TM) systems that await exploration and scientific validation using modern medicine principles. Surprisingly, there is a lack of reported activities to train modern medicine practitioners in TM research in the literature. Recognising this need, a structured training program was planned and conducted under the auspices of the Indian Council of Medical Research (ICMR) to train modern medicine practitioners in TM research. A survey was conducted among modern medicine practitioners to assess training gaps and identify key areas to be covered in the workshop modules. The workshop received a positive response, as evidenced by the numerous registration applications and positive feedback from participants. The present article shares the experiences of conducting the pilot workshop, which may serve as a valuable resource for planning similar workshops.

Analysis of Informed Consent Forms Submitted to Institutional Ethics Committee of a Medical Institute in Southern India: A Cross-sectional Observational Study

Introduction: Informed consent is an essential component in research involving human participants. However, the informed consent obtained may be incomplete and not fulfill the essential criteria of Informed Consent Forms (ICFs). Although the guidelines for developing ICFs have been clearly spelled out by various research bodies, these guidelines are not followed completely. Aim: To analyse the ICFs submitted to the Institutional Ethics Committee (IEC) of a Medical Institute in Southern India. Materials and Methods: The present study was a crosssectional observational study analysing ICFs submitted to the IEC of McGann District Teaching Hospital, Shimoga Institute of Medical Sciences (SIMS), Shivamogga, Karnataka, India, for the period 2014 to January 2023. All research projects containing ICFs during the study period were included in the study. Of the research projects submitted, only 70 had ICFs, and these were subjected to analysis as per Indian Council of Medical Research (ICMR) guidelines criteria. The criteria for ICFs were: statement of research, purpose/methods of the study, duration/frequency of the study, benefits to participants/community, foreseeable risks, discomfort/inconvenience, confidentiality, payment/ reimbursement for participation. In addition to these, ICFs were also analysed for additional elements as per ICMR criteria for tissue and blood samples. The results were then subjected to descriptive statistical analysis and presented as mean and percentages. Results: Many of the required essential elements were present in nearly 50% of ICFs submitted to the IEC, which include information on the basic purpose/methods of the study 70 (100%), identity of the principal investigator/research team 57 (81.42%), freedom to participate/withdraw from the study 55 (78.57%), confidentiality of records 54 (77.14%), and foreseeable risks, discomfort, and inconvenience to participants 35 (50%). Other essential elements like benefits were present to participants/community 28 (40%), payment/reimbursement for participation 28 (40%), duration and frequency 12 (17.14%), statement of research 9 (12.85%), treatment/compensation for injury 4 (5.71%). Regarding additional elements of ICFs for biological samples, ICFs adhered to the ICMR requirements except none of the submitted forms had any information on the period of storage of biological samples. Conclusion: The ICF is an essential requirement for conducting research. Ensuring adherence of ICF to guidelines is important from a research perspective. The present study concludes that the majority of the essential elements were present in ICFs with a few exceptions like study as research and information on the storage of biological samples, which was nil.

Essential oils extracted from Citrus macroptera and Homalomena aromatica (Spreng.) Schott. exhibit repellent activities against Aedes aegypti (Diptera: Culicidae)

Background & objectives: Mosquitoes alone transmit diseases to around 700 million individuals annually, killing approximately 0.7 million people every year worldwide. Considering the potential health risks linked with synthetic repellents, it has become vital to identify eco-friendly, natural repellents for mosquito control as well as to understand the underlying mechanism for mosquito repellent activity. To address this, objectives were set to extract essential oils from Citrus macroptera peel and Homalomena aromatica (Spreng.) Schott. rhizomes, evaluate their mosquito repellent activity against Aedes aegypti, and further explore their mosquito odorant receptor inhibition potential. Methods: The oils were extracted using Clevenger’s apparatus, and properties like specific gravity, refractive index, and boiling point were evaluated and characterised using Fourier transform infrared spectroscopy (FTIR) and gas chromatography-mass spectroscopy (GC-MS). Aedes aegypti mosquito eggs collected from the Indian Council of Medical Research (ICMR), Dibrugarh, were reared in the Department of Pharmaceutical Sciences, Research Laboratory, to obtain adult Aedes aegypti mosquitoes for the mosquito repellent activity evaluation of the essential oils using the Human Bait technique’. Molecular docking studies were performed for the oil components against mosquito odorant binding proteins. Further, toxicity studies of these two oils were evaluated against human dermal fibroblast adult (HDFa) cells. Results: The results revealed the presence of limonene (86.76%) and linalool (52.35%), respectively, in Citrus macroptera and Homalomena aromatica oils. It was found that the combination of the oils in a ratio of 1:1 showed mosquito repellent activity for up to 6.33 ± 0.23 h. Molecular docking studies showed the presence of major oil components having mosquito odorant receptor blocking potential comparable to N, N-diethyl-meta-toluamide (DEET), indicating a rationale for extended mosquito repellent action. Further, both of these oils were found to be non-cytotoxic against HDFa cells after 24 h. Interpretation & conclusion: The encouraging mosquito repellent activity of these two oils as compared to synthetic mosquito repellent DEET might pave the way for the development of novel herbal mosquito repellent formulations containing these essential oils.

Assessment of Prescribing Pattern of Anti-diabetic Drugs in a Tertiary Care Teaching Hospital

Background: There is increasing importance of PPMS because of a boost in marketing of new drugs, variations in pattern of prescribing and consumption of drugs, growing concern about delayed adverse effects, and cost of drugs and volume of prescription. Diabetes mellitus is a pandemic disease that has struck each corner of the world. According to the Indian Council of Medical Research – Indian study (ICMR), a national diabetes study, India currently has 62.4 million people with diabetes. This is set to increase to over 100 million by 2030. Objective: The aim of this study is to evaluate the prescribing pattern of drugs used to treat Diabetes Mellitus in a tertiary care teaching hospital. Methodology: A hospital based retrospective cross-sectional observational study was performed in Navodaya Medical College & Hospital, Raichur over a period of 6 months from May 2022 to October 2022. The study was performed among 80 patients having diabetes mellitus and associated comorbidities that satisfy the study criteria. Results: In this study, among 80 cases of DM diseases assessed, the incidence of diabetes mellitus is common in females (51.25%) than males (48.75%). Most frequently prescribed combination was the insulin, metformin (25%) followed by metformin, glimepiride (12.5%). Among three drug combination was most prescribed metformin, glipizide, and insulin (10%) Conclusion: Diabetes should be managed properly to enhance the quality of life of patients. metformin is the most common choice of oral antidiabetic drugs, but the use of insulin preparation treatment of type 2 DM is increasing continuously. Metformin is the most prescribed antidiabetic drugs in monotherapy.