Use of Complementary and Alternative Medicine (CAM) and Home Remedies by COVID-19 Patients: A Telephonic Survey.

COVID-19 is caused by a novel coronavirus which was first reported in Wuhan city, China. The pandemic has led to considerable mortality globally. India, at present has the second largest burden of COVID-19 cases globally. Clinical trials with new interventions, including new vaccine candidates are being explored in the scientific world. Countries like China and India, with a rich history of traditional medicine, are exploring the effectiveness of traditional medicines to treat COVID-19. This study included 725 patients from an Isolation center, of which 230 (31.7%) were excluded due to reasons like incorrect phone numbers, no response on phone, or denying consent to participate. Finally, 495 participants had responded, of which 367 (74.1%) had not used any Complementary and Alternative Medicine (CAM) product or home remedies while 128 (25.8%) people used 161 CAM products and home remedies during the treatment and even afterward. More than half of the participants (59.6%) among them had consumed Ayurvedic Kadha. Many respondents consumed more than one CAM products or home remedies but there were no reported acute or severe adverse effects with these products. However, it is essential to ensure the safety of these interventions on long-term use because patients with other comorbidities can have a detrimental effect due to these products or due to drug herb interaction with their ongoing medications. Hence, long-term follow-up studies of recovered patients are crucial in determining the effects of medications or CAM products on organ functions due to disease or interventions.

Snapshot of COVID-19 Related Clinical Trials in India.

Many interventions are being explored for the prophylaxis and treatment of COVID-19 in all over the world including India. There was a need of systematic data about the COVID-19 related clinical trials conducted in India. The aim of the present study was to analyze various clinical trials registered in Clinical Trial Registry of India (CTRI) exploring the interventions for COVID 19. The data of various clinical trials being conducted in India was obtained from CTRI. Different trial characteristics were extracted in the predesigned proforma and analyzed. Values were expressed in frequency and percentages. As of 11th July, 2020, a total of 203 trials were registered in the CTRI. The majority of the trials (61%) were related to the AYUSH interventions. Only 3 trials were international while the others were national. A major portion of public and private funding were dedicated to the AYUSH trials. More number of trials were for treatment as compared to prophylaxis. Maharashtra and Delhi are having highest number of trial sites. There is a good progress regarding AYUSH clinical trials, and a similar progress is expected for allopathic interventions.

Analysis of Neurological Adverse Events Reported in VigiBase From COVID-19 Vaccines.

BACKGROUND: Fifteen COVID-19 vaccines have been granted emergency approval before the completion of conventional phases of clinical trials. The present study aimed to analyze the neurological adverse events (AEs) post-COVID-19 vaccination and focuses on determining the association of AEs with the vaccine. METHODOLOGY: The neurological AEs reported for COVID-19 vaccines in the WHO pharmacovigilance database (VigiBase) were extracted from the System Organ Classes - neurological disorders and investigations. Descriptive statistics are reported as percentage and frequency and the disproportionality analysis was also conducted. RESULTS:  For the neurological system, 19,529 AEs were reported. Of these, 15,638 events were reported from BNT162b2 vaccine, 2,751 from AZD1222 vaccine, 1,075 from mRNA-1273 vaccine, eight from Vero vaccine, two from Covaxin, and for 55 AEs, vaccine name was not mentioned. The reason for more AEs reported with BNT162b2 can be maximum vaccination with BNT162b2 vaccine in the study period. According to the disproportionality analysis based on IC025 value, ageusia, anosmia, burning sensation, dizziness, facial paralysis, headache, hypoaesthesia, lethargy, migraine, neuralgia, paresis, parosmia, poor sleep quality, seizure, transient ischemic attack, and tremor are some of the AEs that can be associated with the administration of the vaccine. CONCLUSION: The vaccines should be monitored for these AEs till the causality of these AEs with COVID-19 vaccines is established through further long-term follow-up studies. These neurological AEs reported in VigiBase should not be taken as conclusive and mass vaccination should be carried out to control the pandemic until a definite link of these adverse effects is established.

A comprehensive insight on the COVID-19 vaccine candidates.

The world is currently facing a pandemic triggered by the novel corona virus (SARS - CoV2), which causes a highly infectious infection that predominantly affects the lungs, resulting in a variety of clinical symptoms some cases may be asymptomatic while others may result in to severe respiratory disorder, if the infection is left unattended it may result in multi-organ failure and eventually death of the patient. The transmission of infection is by droplet and fomites of the infected person. The incubation period of virus is from 2 to 14 days. Most common symptoms resemble flu-like but later progress to pneumonia along with dyspnoea and worsening of oxygen saturation, thus requiring ventilator support. The diagnostic modalities include Reverse transcriptase real time PCR (Quantitative Reverse transcriptase polymerase chain reaction) which is recommended method used for diagnosis of the COVID-19 infection using oro-pharyngeal or nasopharyngeal swabs of the patients. Recently serological tests for antigen and antibody detection has been approved by ICMR. Till now, nine COVID-19 vaccines are granted emergency approval for prevention and for the management of infection symptomatic and supportive measures are being adopted. Globally major pharmaceutical firms are engrossed for development of a potent vaccine candidate. This review highlights on various vaccine candidates under clinical trials.

Tocilizumab in COVID-19: a study of adverse drug events reported in the WHO database.

BACKGROUND: Elevated inflammatory cytokines in Coronavirus disease 2019 (COVID-19) affect the lungs leading to pneumonitis with a poor prognosis. Tocilizumab, a type of humanized monoclonal antibody antagonizing interleukin-6 receptors, is currently utilized to treat COVID-19. The present study reviews tocilizumab adverse drug events (ADEs) reported in the World Health Organization (WHO) pharmacovigilance database. RESEARCH DESIGN AND METHODS: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system. RESULTS: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas. CONCLUSION: Neutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.

Relationship between clinical trials and disease burden of India: A cross-sectional study.

BACKGROUND: Research output/efforts in a country should be reflective of the disease burden. India is a site for several national and multinational clinical trials. However, whether clinical trials performed in India reflect the disease burden is not well known. OBJECTIVES: The aim of this study was to evaluate the relationship between disease burden and clinical trials performed in India. MATERIALS AND METHODS: We extracted data on the disease burden from the World Health Organization (WHO) website and on characteristics of clinical trials performed in India from the Clinical Trial Registry of India (CRTI). The correlation between disease burden parameters of overall mortality, disability-adjusted life years (DALYs), years lost due to disability (YLD) and years of life lost (YLL), and the frequency of clinical trials associated with a particular disease was assessed. Additional subgroup analysis according to the number of trial centers, study phase, and medicine type was also performed. RESULTS: Only 18% of clinical trials addressed top 10 diseases associated with 68.3% of overall mortality, and 8% of clinical trials addressed top 10 diseases associated with 52.3% of DALYs. Similarly, 16% of clinical trials addressed top 10 diseases associated with 53.2% YLDs. Furthermore, top 10 diseases associated with 65.9% of YLLs were addressed in only 8% of ongoing clinical trials. The overall correlation between any disease burden parameters with the diseases being explored in clinical trials was poor. CONCLUSION: There is a mismatch between diseases for which clinical trials are happening in the India and the disease burden of India. Measures need to be taken to fulfill this gap between demand and need.

Prevalence of multidrug resistance tuberculosis in adult patients in India: A systematic review and meta-analysis.

BACKGROUND: Multidrug resistance tuberculosis (MDR-TB) is an important public health problem for India but there is a paucity of data related to the prevalence of MDR-TB in India. This systematic review and meta-analysis was designed to synthesize evidence regarding the prevalence of MDR-TB in adult patients in India. METHODS: PubMed and Google Scholar were searched to find different observational studies reporting MDR-TB prevalence in India. Data related to MDR-TB prevalence were pooled for the analysis. PubMed was searched by using different MeSH words. Prevalence was reported with 95% confidence interval (CI). A separate analysis was done for new cases and previously treated cases. Random effect model was used and heterogeneity was assessed by I2 and Cochran Q test. RESULTS: MDR-TB prevalence in new cases were 3% (95% CI 2%-5%, I2 = 95.3%). There was difference in prevalence between different methods of measurement of MDR-TB and study designs. MDR-TB prevalence in previously treated cases was found to be 35% (95% CI 29%-41%, I2 = 98.7%). Results vary with the method of measurement as well as the study design. CONCLUSION: MDR-TB prevalence in previously treated patients was found higher compared to the reported values in national surveys. There is a need for large scale cross-sectional study to verify the findings observed in this review.

Monoclonal Antibodies: A Review.

BACKGROUND: Over the last three decades, monoclonal antibodies (MAbs) have made a striking transformation from scientific tools to powerful human therapeutics. Muromonab CD3 a murine MAb was the first FDA approved therapeutic MAb for the prevention of kidney transplant rejection. Since its approval in 1986, there has been a decline in further application and approvals until the late 1990s when the first chimeric Mab, Rituximab was approved for the treatment of lowgrade B cell lymphoma in 1997. With the approval by licensing authorities of chimeric, followed by humanized and then fully human monoclonal antibodies, the rate of approval and monoclonal antibodies available in the market for the treatment of various diseases has increased dramatically. As of March 2017, FDA has approved approximately 60 therapeutic MAbs which are currently under evaluation in various phases of clinical trials. OBJECTIVE: MAbs are approved for the treatment of diseases belonging to various systems like cardiovascular, respiratory, hematology, kidney, immunology and oncology. MAbs are approved for the treatment of orphan diseases or indications such as paroxysmal nocturnal hemoglobinuria as well as cancers and multiple sclerosis where hundreds of patients are treated and even diseases such as breast cancer, asthma and rheumatoid arthritis where millions are being treated. This review focuses briefly on types, molecular targets, mechanism of actions and therapeutic indications of FDA approved MAb products that are currently available in the market. CONCLUSION: With the advent of fully human MAbs, the efficacy and safety have improved in the treatment of various cardiovascular, cancer, respiratory, hematology, autoimmune diseases and infections. The introduction of biosimilars will increase the affordability and utilization of MAbs in the treatment of various diseases.

Endocannabinoid System: A Multi-Facet Therapeutic Target.

Cannabis sativa is also popularly known as marijuana. It has been cultivated and used by man for recreational and medicinal purposes since many centuries. Study of cannabinoids was at bay for very long time and its therapeutic value could not be adequately harnessed due to its legal status as proscribed drug in most of the countries. The research of drugs acting on endocannabinoid system has seen many ups and downs in the recent past. Presently, it is known that endocannabinoids has role in pathology of many disorders and they also serve "protective role" in many medical conditions. Several diseases like emesis, pain, inflammation, multiple sclerosis, anorexia, epilepsy, glaucoma, schizophrenia, cardiovascular disorders, cancer, obesity, metabolic syndrome related diseases, Parkinson's disease, Huntington's disease, Alzheimer's disease and Tourette's syndrome could possibly be treated by drugs modulating endocannabinoid system. Presently, cannabinoid receptor agonists like nabilone and dronabinol are used for reducing the chemotherapy induced vomiting. Sativex (cannabidiol and THC combination) is approved in the UK, Spain and New Zealand to treat spasticity due to multiple sclerosis. In US it is under investigation for cancer pain, another drug Epidiolex (cannabidiol) is also under investigation in US for childhood seizures. Rimonabant, CB1 receptor antagonist appeared as a promising anti-obesity drug during clinical trials but it also exhibited remarkable psychiatric side effect profile. Due to which the US Food and Drug Administration did not approve Rimonabant in US. It sale was also suspended across the EU in 2008. Recent discontinuation of clinical trial related to FAAH inhibitor due to occurrence of serious adverse events in the participating subjects could be discouraging for the research fraternity. Despite some mishaps in clinical trials related to drugs acting on endocannabinoid system, still lot of research is being carried out to explore and establish the therapeutic targets for both cannabinoid receptor agonists and antagonists. One challenge is to develop drugs that target only cannabinoid receptors in a particular tissue and another is to invent drugs that act selectively on cannabinoid receptors located outside the blood brain barrier. Besides this, development of the suitable dosage forms with maximum efficacy and minimum adverse effects is also warranted. Another angle to be introspected for therapeutic abilities of this group of drugs is non-CB1 and non-CB2 receptor targets for cannabinoids. In order to successfully exploit the therapeutic potential of endocannabinoid system, it is imperative to further characterize the endocannabinoid system in terms of identification of the exact cellular location of cannabinoid receptors and their role as "protective" and "disease inducing substance", time-dependent changes in the expression of cannabinoid receptors.

Knowledge, awareness and practice of ethics among doctors in tertiary care hospital.

INTRODUCTION: With the advancement of healthcare and medical research, doctors need to be aware of the basic ethical principles. This cross-sectional study is an attempt to assess the knowledge, awareness, and practice of health-care ethics among health-care professionals. MATERIALS AND METHODS: After taking written informed consent, a standard questionnaire was administered to 117 doctors. No personal information was recorded on the questionnaire so as to ensure the confidentiality and anonymity of participants. Data analysis was done using SPSS version 21 (IBM Corp., Armonk, NY, USA). RESULTS: Statistically significant difference observed between the opinions of consultant and senior resident (SRs) on issues like, adherence to confidentiality; paternalistic attitude of doctors (doctors should do their best for the patient irrespective of patient's opinion); doctor's decision should be final in case of disagreement and interest in learning ethics (P < 0.05). However, no difference reported among them with respect to patient wishes, informing patient regarding wrongdoing, informing close relatives, seeking consent for children and patients' consent for procedures. Furthermore, no significant difference observed between the two with respect to the practice of health-care ethics. Surprisingly, the response of clinical and nonclinical faculty did not differ as far as awareness and practice of ethics were concerned. CONCLUSION: The significant difference is observed in the knowledge, awareness, and practice of ethics among consultants and SRs. Conferences, symposium, and workshops, on health-care ethics, may act as a means of sensitizing doctors and thus will help to bridge this gap and protect the well-being and confidentiality of the patients. Such an effort may bring about harmonious change in the doctor-patient relationship.