ABSTRACT
The most destructive period the world has experienced seems to be behind us. Not a single nation was spared by this disease, and many continue to struggle today. Even after recovering from COVID, patient may continue to experience some post-COVID effects, such as heart irregularities or a decline in lung vitality. In the past three years (2019-2022), the world has witnessed the power of a small entity, a single peculiar virus. Science initially appeared to be helpless in this regard, but due to the emergence of disease, pharmaceutics (the development of anti-covid drugs), immunology (the rapid antigen test), microbiology (the isolation of viruses from infected people), biotechnology (the development of recombinant vaccines), biochemistry (the blood profile, the D-dimer test), and biochemistry (blood profile, D-dimer test), biophysics (PCR, RT-PCR, CT Scan, MRI) had worked together to fight the disease. The results of these efforts are the development of new diagnostic techniques, possible treatment and finally the availability of vaccines against COVID-19. However, it is not proven that the treatment through the traditional medical system is directly active on SARS-CoV-2 but is instead indirectly acting on SARS-CoV-2 effects by improving symptoms derived from the viral disease. In India, the traditional system of medicine and tradition knowledge together worked in the pandemic and proved effective strategies in prevention and treatment of SARS-CoV-2. The use of effective masks, PPE kits, plasma therapy, yoga, lockdowns and social seclusion, use of modern antiviral drugs, monoclonal antibodies, herbal remedies, homoeopathy, hygienic practice, as well as the willpower of people, are all contributing to the fight against COVID. Which methods or practices will be effective against COVID nobody is aware since medical professionals who wear PPE kits do not live longer, and some people in India who remained unprotected and roamed freely were not susceptible to infection. The focus of this review is on the mode of transmission, diagnosis, preventive measures, vaccines currently under development, modern medicine developed against SARS-CoV-2, ayurvedic medicine used during pandemic, homoeopathic medicine used during pandemic, and specific yoga poses that can be used to lessen COVID-related symptoms.
Subject(s)
COVID-19 , SARS-CoV-2 , Humans , COVID-19/prevention & control , COVID-19/epidemiology , COVID-19/therapy , India/epidemiology , SARS-CoV-2/immunology , COVID-19 Vaccines/therapeutic use , Medicine, Ayurvedic , COVID-19 Drug Treatment , Antiviral Agents/therapeutic useABSTRACT
Objective: Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods: Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results: A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions: A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.
Objetivo: Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos: Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados: Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões: Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.
ABSTRACT
Since the beginning of the year, the deadly coronavirus pandemic, better known as coronavirus disease 2019 (COVID-19), brought the entire world to an unprecedented halt. In tandem with the global scenario, researchers in India are actively engaged in the conduct of clinical research to counter the pandemic. This review attempts to provide a comprehensive overview of the COVID-19 research in India including design aspects, through the clinical trials registered in the Clinical Trials Registry - India (CTRI) till June 5, 2020. One hundred and twenty two registered trials on COVID-19 were extracted from the CTRI database. These trials were categorized into modern medicine (n=42), traditional medicine (n=67) and miscellaneous (n=13). Of the 42 modern medicine trials, 28 were on repurposed drugs, used singly (n=24) or in combination (n=4). Of these 28 trials, 23 were to evaluate their therapeutic efficacy in different severities of the disease. There were nine registered trials on cell- and plasma-based therapies, two phytopharmaceutical trials and three vaccine trials. The traditional medicine trials category majorly comprised Ayurveda (n=45), followed by homeopathy (n=14) and others (n=8) from Yoga, Siddha and Unani. Among the traditional medicine category, 31 trials were prophylactic and 36 were therapeutic, mostly conducted on asymptomatic or mild-to-moderate COVID-19 patients. This review would showcase the research being conducted on COVID-19 in the country and highlight the research gaps to steer further studies.
Subject(s)
Biomedical Research/trends , COVID-19 , Registries , Clinical Trials as Topic , Humans , India/epidemiologyABSTRACT
Traditional Indian medical practices (Ayurveda, Siddha, Unani, and homeopathy) are a vast reservoir of knowledge about medicinal plants. The promising pharmacological properties of these plants have paved the way for developing therapy against novel Coronavirus (CoV) infection. The current review will summarize published works of literature on the effects of traditional Indian medicinal plants against acute respiratory infection (COVID-19, SARS, Influenza, and Respiratory syncytial virus infection) and registered clinical trials of traditional Indian herbal medicines in COVID-19. The current study aims to comprehensively evaluate the data of traditional Indian medicinal plants to warrant their use in COVID-19 management. PubMed, Embase, and Cochrane databases were searched along with different clinical trial databases. A total of 22 relevant traditional Indian medicinal plants (35 relevant studies) were included in the current study having potential antiviral properties against virus-induced respiratory illness along with promising immunomodulatory and thrombolytic properties. Further, 36 randomized and nonrandomized registered clinical trials were also included that were aimed at evaluating the efficacy of herbal plants or their formulations in COVID-19 management. The antiviral, immunomodulatory, and thrombolytic activities of the traditional Indian medicinal plants laid down a strong rationale for their use in developing therapies against SARS-CoV-2 infection. The study identified some important potential traditional Indian medicinal herbs such as Ocimum tenuiflorum, Tinospora cordifolia, Achyranthes bidentata, Cinnamomum cassia, Cydonia oblonga, Embelin ribes, Justicia adhatoda, Momordica charantia, Withania somnifera, Zingiber officinale, Camphor, and Kabusura kudineer, which could be used in therapeutic strategies against SARS-CoV-2 infection.
Subject(s)
COVID-19 Drug Treatment , Medicine, Ayurvedic , Plant Preparations/therapeutic use , Plants, Medicinal , Humans , India , Plants, Medicinal/chemistry , Randomized Controlled Trials as TopicABSTRACT
The COVID-19 pandemic necessitated a global paradigm shift in the teaching of human anatomy. Most institutions successfully transitioned from traditional in-person teaching methods, to various distance-learning strategies. Since virtual reality (VR) offers immersive three-dimensional (3D) experiences, this study investigated students' experiences regarding the capacity of VR to support distance-learning of anatomy. Using the VR application, 3D Organon Virtual Reality Anatomy, anatomy instructors pre-recorded learning content as 360-degree videos with live voice-over and integrated it into the teaching material of the MBBS first-year abdomen, pelvis, and perineum-structure and function course. A 19-item 5-point Likert scale questionnaire, comprising of two major categories, "VR experience in anatomy lessons" and "VR in anatomy lessons vs. traditional cadaveric dissection" was disseminated. Post-evaluation analysis revealed a response rate of 63.5%. Almost 70% of students agreed that VR was instrumental in solidifying their theoretical understanding and improved spatial awareness with better retention of anatomical relationships. Approximately 50% wanted to continue using VR even if instruction becomes onsite. Though 72% of participants agree that VR addressed the session learning objectives only 24% agree that it is similar or better than cadaveric dissection, thus preferring cadaveric dissection to VR. Only 12.1% agree that VR is more beneficial to cadaveric dissection. Our exploration into the integration of VR technology in anatomy teaching has revealed promising opportunities. While VR can augment traditional teaching methods in unprecedented times such as war, floods or global pandemic, it should not replace hands-on cadaveric learning entirely, but rather complement existing approaches.
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Objectives: Evidence suggests that post-coronavirus disease 2019 (COVID-19) is associated with reduced health-related quality of life, and up to 80% of those infected with COVID-19 may experience these symptoms. The objective of the present study was to identify the effects of individualized homeopathic medicinal products (IHMPs) against placebos in postCOVID-19 conditions. Design: Double-blind, randomized (1:1), two parallel arms, placebo-controlled, feasibility trial. Setting: D. N. De Homoeopathic Medical College & Hospital, Kolkata, West Bengal, India. Subjects: Sixty participants with post-COVID-19 conditions. Interventions: Group verum (n = 30; IHMPs plus concomitant care) versus group control (n = 30; placebos plus concomitant care). Outcome Measures: Feasibility issues; primary-post-COVID-19 symptoms checklist; secondary-Measure Yourself Medical Outcomes Profile version 2 (MYMOP-2); all of them were measured at baseline, and monthly intervals, up to 3 months. The intention-to-treat sample was analyzed; group differences were reported using descriptive statistics: means, 95% confidence intervals (CIs), and between group effect sizes (Cohen's d). Results: Feasibility concerns showed promise; recruitment, retention, and attrition rates were 34.2%, 95%, and 5%, respectively. Group differences in both primary and secondary outcomes favored IHMPs against placebos: symptoms checklist score mean difference after 3 months: -4.2, 95% CI -4.9 to -3.4, d = 2.854 and MYMOP-2 mean difference after 3 months: -2.2, 95% CI -2.8 to -1.7, d = 2.082, respectively. Natrum muriaticum (11.7%), Pulsatilla nigricans (10%), Rhus toxicodendron (8.3%), and Calcarea carbonica (8.3%) were the most frequently prescribed remedies. Conclusions: IHMPs produced better results than placebos in reducing symptoms checklist scores and MYMOP-2 scores in the treatment of post-COVID-19 conditions. Definitive trials are warranted to confirm the findings.
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Background: Ayush (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) system of medicine has been extensively used in India for the prevention and management of coronavirus disease 2019 (COVID-19). The present report is the second update of a living systematic review and meta-analysis and has been intended to assess the preventive potential and safety of Ayush drugs against COVID-19. Methods: A search of databases such as PubMed, the Cochrane central register of controlled trials, the World Health Organization (WHO) COVID-19 database, the clinical trial registry-India, the AYUSH research portal, and preprint repositories was performed till March 1, 2023. Randomized controlled trials or analytical observational studies were included. Incidences of COVID-19 infections and mortality were taken as primary outcome measures; and symptomatic severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection, incidences of hospital admissions, and adverse events were taken as secondary outcomes. The risk of bias was evaluated by version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB-2) and the Risk of Bias in Non-Randomized Studies-of Interventions (ROBINS-I) tool. Data were synthesized through the RevMan 5.4 tool, and the certainty of the evidence was ranked through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: Out of 2350 articles, 15 studies were included in the review. The pooled estimate of Guduchi [Tinospora cordifolia (Thunb.) Miers], Chyawanprasha, and Ayuraksha kit was obtained. Meta-analysis of the data suggested that Guduchi may reduce the incidences of COVID-19 infections (risk ratio [RR]: 0.67 [95% confidence interval, CI: 0.48-0.95]) and the symptom development among the infected (RR: 0.88 [95% CI: 0.73-1.08]), however, no change was observed in hospital admissions (RR: 0.96 [95% CI: 0.20-4.53]). It is uncertain that Chyawanprasha reduces the incidence of COVID-19 infection (RR: 0.28; [95% CI: 0.07-1.08]). Ayuraksha kit as chemoprophylaxis may reduce the incidences of COVID-19 infections (RR: 0.49; [95% CI: 0.32-0.77]). The certainty of the evidence was low to moderate mainly due to the serious risk of bias. Conclusion: Prophylactic use of Ayush medicines for populations at risk may help to prevent COVID-19 infection by reducing incidence and severity. However, considering the certainty and fewer studies, high-quality studies are still desired to confirm the efficacy and safety of Ayush chemoprophylaxis for COVID-19. Nevertheless, this update will serve as a torchbearer for policymakers, physicians, and other stakeholders for their decision-making through evidence-based medicine.
Subject(s)
COVID-19 , Medicine, Ayurvedic , Pandemics , SARS-CoV-2 , Humans , COVID-19/prevention & control , COVID-19/epidemiology , Pandemics/prevention & control , India/epidemiology , Coronavirus Infections/prevention & control , Coronavirus Infections/epidemiology , Pneumonia, Viral/prevention & control , Pneumonia, Viral/epidemiology , Betacoronavirus/drug effects , COVID-19 Drug Treatment , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: The common cold is one of the most frequently occurring illnesses worldwide. The aim of this study was to determine which OTC anti-common cold medications were most often recommended by pharmacists and if the COVID-19 pandemic affected such recommendations. METHODS: Non-interventional, observational research trial using a self-developed questionnaire to collect data on pharmacists' recommendations for anti-common cold OTC treatment. The data were collected during the COVID-19 pandemic (December 2021-February 2022) in four large community network pharmacies in Lodz (Poland) and then compared with an analogue period of time before the pandemic (December 2019-February 2020). RESULTS: During COVID-19 pandemic there was a significant (p < 0.05) reduction in paracetamol, acetylsalicylic acid, metamizole magnesium, inosines, alpha-mimetics, mucolytics, homeopathics, and sore throat products and an increase in other tablets/capsules and add-on product recommendations. There was a significant relationship (p < 0.05, OR > 1) between the recommended frequency of paracetamol, inosines, sore throat products (each symptom), metamizole magnesium (headache, fever), acetylsalicylic acid (headache, fever, fatigue), NSAIDs, alpha-mimetics (headache, rhinorrhea), pseudoephedrine (rhinorrhea), homeopathics (headache), herbal products (fatigue), antihistamines (rhinorrhea, cough), and mucolytics (headache, fever, cough). CONCLUSIONS: Favorable prices (before COVID-19 pandemic) and reports on common NSAIDs side effects (beginning of the pandemic) led to high sale of paracetamol. Increased awareness of clinical effectiveness of some medications or their reduced availability influenced their limited recommendations.
Subject(s)
COVID-19 , Common Cold , Pharyngitis , Humans , Acetaminophen/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Aspirin/therapeutic use , Common Cold/drug therapy , Common Cold/chemically induced , Cough , Expectorants/therapeutic use , Headache/chemically induced , Headache/drug therapy , Nonprescription Drugs/therapeutic use , Pandemics , Pharmacists , Pharyngitis/chemically induced , Pharyngitis/drug therapy , RhinorrheaABSTRACT
INTRODUCTION: The coronavirus disease 2019 (COVID-19) is leading to unknown and unusual health conditions that are challenging to manage. Post-COVID-19 fatigue is one of those challenges, becoming increasingly common as the pandemic evolves, as it impairs the quality of life of an individual. This trial attempts to identify the preliminary evidence of the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of post-COVID-19 fatigue in adults. METHODS: A 3-month, single-blind, randomized, placebo-controlled, parallel-arm trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, India. Sixty participants were randomized in a 1:1 ratio to receive either IHMs (n = 30) or identical-looking placebos (n = 30). The primary and secondary outcome measures were the Fatigue Assessment Scale (FAS) and Outcome in Relation to Impact on Daily Living (ORIDL), respectively, measured every month, for up to 3 months. Comparative analysis was carried out on the intention-to-treat sample to detect group differences. RESULTS: Group differences in both the primary (FAS total: F1, 58 = 14.356, p < 0.001) and secondary outcomes (ORIDL: F1, 58 = 210.986, p < 0.001) after 3 months favored IHMs against placebos. Lycopodium clavatum (11.7%), sulfur (11.7%), Arsenicum album (10%), and Thuja occidentalis (10%) were the most frequently indicated medicines. No harm, unintended effects, homeopathic aggravations, or any serious adverse events were reported from either of the groups. CONCLUSION: IHMs produced significantly better effects than placebos in the treatment of post-COVID-19 fatigue in adults. Definitive robust trials may be undertaken to confirm the findings.
Subject(s)
COVID-19 , Materia Medica , Adult , Humans , COVID-19/therapy , India , Quality of Life , Single-Blind Method , SulfurABSTRACT
Homeopathy was founded some two hundred years ago by Dr Samuel Christian Hahnemann. Over time, it has grown to be among the most frequently used forms of alternative medicine in Europe and the USA. It is underpinned by the principle of 'like cures like', where highly diluted substances are used for therapeutic purposes, by producing similar symptoms to when the substance is used in healthy people. Many studies have been published on the value of homeopathy in treating diseases such as cancer, depression, psoriasis, allergic rhinitis, asthma, otitis, migraine, neuroses, allergies, joint disease, insomnia, sinusitis, urinary tract infections and acne, to name a few. We conducted a comprehensive review of the literature on homeopathy and evaluated its effectiveness in clinical practice. While there is evidence of the clinical benefits of homeopathy, its formal application requires more rigorous randomised controlled trials.
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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.
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INTRODUCTION: Homeopathic medicines have been used for decades in the prevention and treatment of infectious diseases. However, the preventive efficacy of specific homeopathic medicines in COVID-19 is not well characterized. This study aimed to evaluate the comparative efficacy of prespecified homeopathic medicines in preventing COVID-19. METHODS: A community-based, double-blind, randomized, placebo-controlled trial was conducted on 4,034 participants residing in Ward No. 27 of the Howrah Municipal Corporation in India. Participants were randomized to receive one of three prespecified homeopathic medicines [Influenzinum 30C, Arsenicum album 30C, Anas barbariae hepatis et cordis extractum 200K (Oscillococcinum®)], or placebo. The outcomes were the incidence of laboratory-confirmed and suspected cases of COVID-19 during a follow-up period of 1 month. RESULTS: During the follow-up period, a total of 13 new laboratory-confirmed COVID-19 cases were reported in the study population. Among these, 5 cases in Influenzinum group, 2 cases in Arsenicum album group, 1 case in Oscillococcinum® group, and 5 cases in Placebo group were reported. On the other hand, number of suspected COVID-19 cases was significantly less in all the three homeopathic medicine groups compared to placebo. The least number of suspected cases reported in the Oscillococcinum® group (aOR: 0.058; 95% confidence interval [CI]: 0.029, 0.114), followed by the Arsenicum album (aOR: 0.337; 95% CI: 0.238, 0.475) and Influenzinum (aOR: 0.539; 95% CI: 0.401, 0.726) groups. CONCLUSION: Prespecified homeopathic medicines, particularly Oscillococcinum® and Arsenicum album 30C, may have a role in preventing COVID-19, especially in reducing the incidence of suspected or COVID-19-like respiratory illnesses. However, the result failed to demonstrate a statistically significant difference in the occurrence of confirmed cases of COVID-19 between the study groups. Further research is needed to evaluate the efficacy of these medicines in different populations and settings.
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BACKGROUND: Post-acute COVID-19 syndrome (PACS) is a well-recognized, complex, systemic disease which is associated with substantial morbidity. There is a paucity of established interventions for the treatment of patients with this syndrome. OBJECTIVES: To systematically review registered trials currently investigating therapeutic modalities for PACS. DATA SOURCES: A search was conducted up to the 16 September, 2022, using the COVID-19 section of the WHO Internal Clinical Trials Registry Platform. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: Interventional clinical trials of any sample size examining any therapeutic modality targeting persistent symptoms among individuals after diagnosis with COVID-19. METHODS: Data on trial characteristics and intervention characteristics were collected and summarized. RESULTS: After screening 17 125 trials, 388 trials, from 42 countries, were eligible. In total, we had 406 interventions, of which 368 were mono-therapeutic strategies, whereas 38 were intervention combinations. Among 824 primary outcomes identified, there were >300 different outcomes. Rehabilitation was the most employed class of intervention in 169 trials. We encountered 76 trials examining the pharmacological agents of various classes, with the most common agent being colchicine. Complementary and alternative medicine encompassed 64 trials exploring traditional Chinese medicine, Ayurveda, homeopathic medications, naturopathic medications, vitamins, dietary supplements, and botanicals. Psychotherapeutic and educational interventions were also employed in 12 and 4 trials, respectively. Other interventions, including transcranial direct current stimulation, transcutaneous auricular vagus nerve stimulation, general electrical stimulation, cranial electrotherapy stimulation, various stem cell interventions, and oxygen therapy interventions, were also employed. CONCLUSION: We identified 388 registered trials, with a high degree of heterogeneity, exploring 144 unique mono-therapeutic interventions for PACS. Most studies target general alleviation of symptoms. There is a need for further high-quality and methodologically robust PACS treatment trials to be conducted with standardization of outcomes while following WHO's recommendation for uniform evaluation and treatment.
Subject(s)
COVID-19 , Transcranial Direct Current Stimulation , Humans , COVID-19/therapy , SARS-CoV-2 , Post-Acute COVID-19 Syndrome , World Health OrganizationABSTRACT
OBJECTIVE: During the early part of the COVID-19 pandemic, non-pharmacologic interventions were the strategies for the prevention of severe acute respiratory syndrome coronavirus 2. The Ministry of Ayush, Govt. of India, had advised Arsenicum album 30C as a prophylactic to prevent COVID-19. This study was undertaken to evaluate the protective efficacy and safety of the Arsenicum album 30C. METHODS: We conducted a prospective, multicenter, cluster-randomized, parallel-arm, community-based, open-label study involving apparently healthy individuals residing in containment areas of 7 cities in India. Clusters are defined as the population residing in the containment areas, who are under restriction for movement. Forty-two clusters were randomly assigned at 2:1 to the Arsenicum album 30C group (30 clusters) or to the control group (12 clusters, which received no specific therapy). The medicine was given twice daily for 7 days. The primary outcome was the incidence of COVID-19, as per the case definition notified by the National Centre for Disease Control, Government of India, during 3-week follow-up period. RESULTS: The analysis included 32,186 individuals residing in 42 clusters (containment areas). A total of 22,693 individuals from 30 clusters received Arsenicum album 30C, and 9,493 individuals from 12 clusters were observed in the control group. The overall protective effect of the Arsenicum album 30C was 80.22% (95% confidence interval [CI], 71.16-86.44; 40 cases per 22,693 [6.04 per 10,000 person-weeks] in the Arsenicum album 30C group vs. 84 cases per 9,493 [29.78 per 10,000 person-weeks] in the control group). The protective effect of the Arsenicum album 30C against laboratory-confirmed COVID-19 was 68.22% (95% [CI], 49.64-80; 32 cases per 22,693 [4.83 per 10,000 person-weeks] in the Arsenicum album 30C group vs. 42 cases per 9,493 [14.93 per 10,000 person-weeks] in the control group). Adverse effects observed in both groups were mild and resolved without medication and sequelae. CONCLUSION: Homeopathic medicine Arsenicum album 30C was associated with a decrease in the incidence and provided some protection against COVID-19 as compared to nontreatment. Further randomized, double-blind, placebo-controlled trials may be conducted to validate the results of this study.
Subject(s)
COVID-19 , Materia Medica , Male , Humans , Pandemics , Prospective Studies , COVID-19/prevention & control , SARS-CoV-2ABSTRACT
Background and Objective: In 2019, a novel coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) was declared pandemic. Advancement in computational technology has provided rapid and cost-effective techniques to test the efficacy of newer therapeutic agents. This study evaluated some of the potent phytochemicals obtained from AYUSH (Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homeopathy)-listed medicinal plants against SARS-CoV-2 proteins using computational techniques. Materials and methods: The potential SARS-CoV-2 protein targets were utilized to study the ligand-protein binding characteristics. The bioactive agents were obtained from ashwagandha, liquorice, amla, neem, tinospora, pepper, and stevia. Ivermectin was utilized as a reference agent to compare its efficacy with phytochemicals. Results: The computational analysis suggested that all the bioactive components from the selected plants possessed negative docking scores (ranging from -6.24 to -10.53). The phytoconstituents were well absorbed, distributed in the body except for the CNS, metabolized by liver enzymes, well cleared from the body, and well tolerated. The data suggest that AYUSH-recommended plants demonstrated therapeutic efficacy against SARS CoV-2 virus infection with significantly reduced toxicity. Conclusion: The phytoconstituents were found to hinder the early stages of infection, such as absorption and penetration, while ivermectin prevented the passage of genetic material from the cytoplasm to the nucleus. Additional research involving living tissues and clinical trials are suggested to corroborate the computational findings.
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PURPOSE: The COVID-19 pandemic has disrupted healthcare access and telemedicine has been widely deployed. The aim of this study is to assess the impact of this health crisis on treatment consumption and telemedicine development in outpatients treated by oral anti-cancer agents and followed by the Oncoral hospital/community multidisciplinary program where continuity care is maintained by a pharmacist/nurse pair. METHODS: A prospective monocentric study was conducted among cancer patients who received Oncoral telephone follow-up during the 1st lockdown in France using a 56-item questionnaire which covered sociodemographic data, patient medication management, and telehealth. RESULTS: 178 patients received Oncoral follow-up during the 1st lockdown and 67.4% responded to the questionnaire. During lockdown, 9.2% of patients took medication or CAM for fatigue, 6.7% for mood alteration, 10.8% for sleep disorder, 11.7% for stress and anxiety, and 12.5% to get more energy. Homeopathy consumption was triggered by the pandemic. Habits about getting drugs from the pharmacy changed significantly (p < 0.001), while other treatment habits did not. 83% of patients were satisfied by the telephone follow-up established, 69% would be in favor of repeating this in case of a new epidemic wave. Those most in favor of using telemedicine seemed to be the youngest (p < 0.001), with several dependent children (p < 0.007), high school degree or higher education (p = 0.023), and in work (p < 0.001). CONCLUSION: Health system reorganization enables to limit the impact of the crisis on patients' drug use in oncology care. Telemedicine is a promising public health tool.
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BACKGROUND: During the early phases of Covid-19, social media platforms became a significant source of misinformation, and India emerged as a global hotspot. Studies show that 'miracle cure' for preventing and treating Covid-19 infection has been a prominent topic of misinformation. This study explores the extent to which beliefs in cure for Covid-19 in three prominent medical traditions popular in India are associated with the exposure to and trust in various sources from which the public access information. METHODS: We conducted an online structured questionnaire survey of 500 respondents in August 2020 in four major cities of India. RESULTS: Despite the scientific consensus at that time that there was no cure for Covid-19, close to three-quarters of our respondents believe that there was a cure in at least one of the three popular medical traditions in India: Allopathy, Homeopathy, and Ayurveda. We find that exposure to and trust in WhatsApp are associated with false beliefs regarding the existence of a cure for Covid-19 (p = 0.001 and p = 0.014, respectively). While trust in science is associated with correct beliefs (p = 0.025), there is evidence that trust in government information may foster incorrect beliefs (p = 0.031). CONCLUSIONS: The high trust in scientific research and its potential ability to instill correct beliefs could be exploited to combat Covid-19 misinformation in India. Potential interventions such as awareness campaigns to increase digital media literacy, regulating social media platforms, and voluntary content regulation by social media platforms - might help policymakers tackle Covid-19 related misinformation effectively.
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COVID-19 , Humans , Internet , Access to Information , Cities , India/epidemiologyABSTRACT
Introduction During the active phase of the COVID-19 pandemic, the global healthcare system failed to meet the increased demand for healthcare resources, infrastructures, and facilities. The brunt of the healthcare crisis was faced not only by COVID-19 victims; a large majority of non-COVID patients were deprived of routine and emergency care. Factors that possibly affected resource utilization, healthcare-seeking behavior, service delivery patterns, and national health systems' priority during the pandemic were the knowledge and attitudinal concerns related to the COVID-19 disease and its control measures. Here, we evaluated the knowledge, concern, and psychological distress among the caregivers of the patients attending the emergency department at a tertiary healthcare center in India.â Methodology We conducted a survey-based study using a pre-validated questionnaire on the caregivers of the patients visiting the emergency department (ED) from June to September 2020 (during the first wave of the COVID-19 pandemic). The demographic details and responses of the participants were documented in the semi-structured proforma. A pre-validated COVID-19 Peritraumatic Distress Index (CPDI) questionnaire was used to assess psychological stress. Results Out of 1014 participants interviewed, the majority were male attendants (72%), aged 18-45 (82%), and seeking medical attention for patients with chronic illnesses (76%). Acute onset emergencies like stroke, myocardial infarction, trauma, etc. were the ED presentation in only one-fifth of patients. COVID-19-related knowledge was adequate for questions related to age groups at risk for the viral infection (97% agreed that all age groups were at risk), mode of transmission (75-90% were aware of the common modes of transmission), and >65% knew the common symptoms of COVID-19 infection. However, only 38.5% knew about frequent handwashing as a protective measure. More than half of the participants considered the COVID-19 vaccine as the sole ray of hope and disregarded the effectiveness of alternative medicines such as Ayurvedic/homeopathic/allopathic medicines as preventive options. One-third were first-time visitors to the hospital, while two-thirds of all participants were afraid to visit any hospital during the COVID-19 pandemic. The majority (84%) faced difficulty in accessing the index tertiary care center due to transport, socioeconomic support, or lockdown-related restrictions. In comparison, 60% reported some form of discrimination at almost all levels of healthcare settings due to COVID-19-related priority changes. Nearly half (48%) of all enrolled caregivers reported experiencing mild-to-moderate distress (CPDI score=28-51), and 15.7% felt severe distress (CPDI score >51) while seeking treatment for the non-COVID-19 illness of their patient. Age and socioeconomic status were significantly associated with COVID-19-related psychological distress levels (p<0.001 in logistic regression), while gender, education, and residence showed no significant associations. Conclusion Most of the patient caregivers visiting the emergency department during the COVID-19 pandemic had an adequate understanding of risk factors and preventive measures. The major barriers to accessing healthcare facilities were transport, financial issues, and lockdown-related restrictions. Almost two-thirds of the caregivers revealed mild-to-moderate to severe psychological distress due to the pandemic and lockdown-related concerns.
ABSTRACT
BACKGROUND: COVID-19 is a recent major public health concern caused by the SARS-CoV-2 virus, with approximately 44.6 million COVID-19-positive cases and 530,000 deaths in India (as of February 1, 2023). The COVID-19 vaccination drive in India was initiated in January 2021; however, an effective preventive strategy with high efficacy and immunological safety remains elusive. OBJECTIVE: The aim of this study is to assess the immunogenic responses of Arsenicum album 30CH (AA30CH) as COVID-19 prophylaxis, including assessment of immunological markers, innate and acquired immune responses, COVID-19 symptoms, and its associated antibody responses. METHODS: This randomized controlled clinical trial (RCT) will include two parallel comparator groups of AA30CH and placebo with an allocation ratio of 1:1 conducted in the Pathanamthitta district of Kerala, India. The placebo or AA30CH will be administered in three intervention schedules and blood samples will be collected before and after each of the intervention schedules. Based on the inclusion and exclusion criteria, 112 participants per arm (with an expected dropout of 20%) will be screened. Immunogenic responses will be evaluated by determining the antigen density and modulation in immunological markers and lymphocyte subsets CD3, CD4, CD8, CD24, CD27, CD38, CD4 interferon-γ, CD4 CD17, CD4 CD25 (activated T lymphocytes), T cells, B cells, dendritic cells (mature and immature), and natural killer cells on days 1, 5, 23,27, 45, 49, and 66. The innate and acquired immune responses will also be evaluated by a real-time reverse-transcriptase polymerase chain reaction (RT-PCR) array profiler (84-gene set) before and after the study interventions. The toxicity status of AA30CH in study participants will be evaluated through hepatic, renal, and hematological parameters and peripheral smears on days 1, 5, 23, 27, 45, 49, and 66. The number of participants developing COVID-19-like symptoms per National Centre for Disease Control guidelines and the number of participants testing positive for COVID-19 in RT-PCR during follow-ups in any of the three intervention schedules will be identified. Moreover, a subgroup analysis will be used to assess the COVID-19 antibody responses between vaccinated and unvaccinated participants. RESULTS: This RCT protocol has been approved by various committees and funded by the Central Council for Research in Homoeopathy, Ministry of Ayush, Government of India. The project has been implemented in collaboration with the Department of Homoeopathy, Government of Kerala. The RCT was rolled out on January 25, 2023, and enrollment was completed April 3, 2023. The immunological assays will be conducted at the Department of Biotechnology-Translational Health Science and Technology Institute, Faridabad, India. CONCLUSIONS: This study will represent the first evaluation of the immunological efficacy and safety of AA30CH in an RCT, which may significantly impact the use of homeopathy as an evidence-based medicine approach. TRIAL REGISTRATION: Clinical Trials Registry-India CTRI/2022/08/045089; https://tinyurl.com/mryrpkvk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48479.
ABSTRACT
INTRODUCTION: The first wave of the coronavirus disease 2019 (COVID-19) pandemic created havoc and confusion in choosing appropriate treatment, as well as prophylaxis, due to its rapid surge, disease novelty, and lack of evidence-based literature. It was even more concerning among the healthcare workers (HCWs), who had to take care of patients, themselves, and their own families. OBJECTIVE: This online survey-based study targeted finding the various options for COVID-19 precautionary or prophylactic measures opted for by HCWs. METHODOLOGY: This was an observational study based on a predesigned questionnaire, which was floated online for three months after institutional ethical approval, just after the first wave of COVID-19 in 2021, targeting HCWs of different cadres (doctors, nurses, paramedics/laboratory technicians, etc.), ages, and sexes and HCWs hailing from across the country. Questions were focused on HCW's adopted measures, the order of preference and its reasons, and concerns related to safety and efficacy. Data was collected through Google Forms (Google, Inc., Mountain View, CA) into an Excel spreadsheet (Microsoft® Corp., Redmond, WA) and analyzed by the latest Statistical Package for Social Sciences (SPSS) software (IBM SPSS Statistics, Armonk, NY) using appropriate statistics. RESULTS: The routine practice of standard precautionary measures (face mask, hand hygiene, and social distancing) and wearing a personal protective equipment (PPE) kit during the care of COVID-19-positive or COVID-19-suspected patients was adopted by the majority of HCWs, i.e., 306/312 (>98%) irrespective of cadre (p = 0.001). After the "routine measures," the most adopted measure by participant HCWs irrespective of profession, age, and gender was the consumption of allopathic drugs (n = 188; 60.26%). Anti-COVID-19 measures in the category of drugs used by healthcare providers (HCPs) were prophylactic allopathic drugs (60.26%), homeopathic drugs (11.86%), and other Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy (AYUSH)/traditional medical system drugs (11.86%). Vitamin C was the most consumed among all of the drugs for COVID-19 prophylaxis purposes. Non-drug measures espoused by the HCPs were physical exercises (46.47%), increased sleep duration (35.89%), change in dietary habits (42.62%), and spiritual measures (19.23%). CONCLUSION: The fear of COVID-19 imposed on the HCPs the obligation to use all the available preventive measures in spite of the lack of evidence on actual benefits. After the routine infection preventive measures, the most adopted measure by participant HCWs irrespective of profession, age, and gender was the consumption of prophylactic allopathic drugs (>60%), and the most non-drug preventive measures were the initiation of physical exercises and change in dietary habits. Adapting some form of physical exercise was more noted with males than females (p = 0.001), and it significantly increased with HCPs of higher age of >25 and >40 years than younger HCPs (58.6% versus 29.3%; p = 0.016). Females preferred more dietary and nutritional modifications.