Publications by authors named "Ajay K Shukla"

Background: Among the elderly, who are often exposed to polypharmacy, explicit deprescribing tools offer clear, validated guidelines for safely reducing medications. However, the effectiveness of these tools varies across healthcare settings and populations. In India, unique sociocultural and healthcare challenges demand a tailored approach to deprescribing for elderly patients, and the need to adapt existing tools to local contexts.

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Primary biliary cholangitis (PBC) is a chronic liver disease leading to liver damage and potentially death. The first-line treatment is ursodeoxycholic acid (UDCA), but some patients do not respond well. Obeticholic acid (OCA) is a second-line treatment option.

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Background: The United States Food and Drug Administration (US FDA) is responsible for ensuring public health by conducting a comprehensive assessment and approval of pharmaceuticals, medical devices, and food products. The federal agency conducts a thorough evaluation of drug safety and efficacy before granting market approval.

Materials And Methods: This retrospective study aimed to analyze all new drug approvals that took place during the 2023 study period using an observational, record-based approach.

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Background: There have been concerns over the rationality of prescribing practices of fixed-dose combinations (FDCs) available in India. The FDC of domperidone and pantoprazole recently emerged as a top-selling product at Janaushadhi Kendras in India.

Methods: This cross-sectional study is a part of the prescription research which was conducted under the Indian Council of Medical Research (ICMR) Task Force Project on Rational Use of Drugs at 13 tertiary healthcare centers across the countries that were part of the ICMR-Rational Use of Medicine Centres Network.

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Purpose: To assess the prevalence of DR and the need for screening and management of DR with medical management of diabetes in rural and tribal population in Maharashtra.

Methods: The known diabetics of rural area and tribal area were screened at corresponding primary health centers, subcenters, and village level with the help of local healthcare workers using a portable non-mydriatic fundus camera. The prevalence of blindness among known diabetics in rural area was 1.

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Background: Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis is one of the top ten causes of death worldwide. Isoniazid (INH) is an important component of anti-tuberculosis therapy (ATT). Low isoniazid levels can serve as a risk factor for the development of treatment failure, relapse of disease and acquired secondary resistance.

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Article Synopsis
  • Donanemab is a humanized monoclonal antibody being developed to treat early onset Alzheimer's disease (AD) by targeting N-truncated pyroglutamate amyloid-peptide (N3pG), which is linked to amyloid plaque formation.
  • The FDA granted the drug breakthrough therapy designation in June 2021, but rejected its accelerated approval in January 2023 due to insufficient safety data, although clinical trials suggest it may delay cognitive decline in mild to moderate AD patients.
  • Further research is required to understand donanemab's long-term therapeutic benefits and its interaction with amyloid plaques and tau levels in patients with cognitive impairment.
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Purpose: This work assesses the change in tear function after LASIK surgery.

Methods: This prospective, observational study was conducted in the Refractive Clinic of a tertiary care rural hospital. Tear dysfunction symptoms and the tear function tests were assessed in 269 eyes of 134 patients, OSDI score was used to document the tear dysfunction symptoms.

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Type 1 diabetes mellitus (T1DM) is an autoimmune condition driven by T lymphocytes that specifically declines the function of beta cells of pancreas. Immunological treatments aim to stop this decline in β-cell function thus preventing TIDM. Although TIDM occur at any age, it is one of the most common chronic disorders in children.

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The COVID-19 pandemic remains a severe global threat, with the world engulfed in the struggle against the disease's second or third waves, which are approaching frightening proportions in terms of cases and mortality in many nations. Despite the critical need for effective therapy, there is still uncertainty about the optimal practices for treating COVID-19 with various pharmaceutical approaches. This being third year, global immunity and eradication of SARS-CoV-2 is currently seems to be out of reach.

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In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive.

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Background: India has seen more than 43 million confirmed cases of COVID-19 as of April 2022, with a recovery rate of 98.8%, resulting in a large section of the population including the healthcare workers (HCWs), susceptible to develop post COVID sequelae. This study was carried out to assess the nature and prevalence of medical sequelae following COVID-19 infection, and risk factors, if any.

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Idiotype-based therapeutics have failed to deliver their promise, necessitating rethinking of the concept and its potential to develop a viable immunotherapy method. The idiotype based hypothesis is discussed in this paper in order to produce effective anti-idiotype vaccinations. Polyclonal anti-idiotype reagents have been shown to be more successful in animal models, and a better understanding of the immune response in humans supports the idea that polyclonal anti-idiotype vaccines will be more effective than monoclonal-based anti-idiotype vaccines.

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The COVID-19 pandemic continues to pose a serious global challenge, with the world engulfed in fighting second, third and fourth waves of the disease, which is reaching scary proportions in terms of cases and mortality in countries like India. Despite the urgent need of proven management protocols, there is still confusion about the best practices for treating COVID-19 with different pharmaceutical interventions. Antimicrobials are empirically used in COVID-19 patients.

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An overview of post COVID sequelae.

J Basic Clin Physiol Pharmacol

November 2022

After healing from COVID-19, patients often experience a slew of symptoms known as post COVID-19 sequelae. Despite the fact that the SARS-CoV-2 pandemic is still ongoing, post-Covid-19 syndrome is already a difficult problem to address: long-term multiorgan sequelae, while frequently described, have yet to be systematized. As a result, post-Covid-19 syndrome can have a major influence on surviving patients' working capacity as well as their personal lives.

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Antibody-dependent enhancement (ADE) can be seen in a variety of viruses. It has a deleterious impact on antibody treatment of viral infection. This effect was first discovered in the dengue virus, and it has since been discovered in the coronavirus.

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Background: The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm.

Materials And Methods: In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018.

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Objective: The objective of the present investigation was to develop a stable and optimized drug-loaded nanoemulsion system using the phase inversion temperature (PIT) method.

Significance: The PIT method has been widely used for the development of food-grade nanoemulsion systems. For the first time, a simple and cost-effective, PIT method was used for the development of a stable drug-loaded nanoemulsion system.

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