Fixed-Dose Combination of Canagliflozin and Metformin as an Adjunct to Diet and Exercise in Indian Adults with Type 2 Diabetes Mellitus: Results from a Multicentric, Open-Label, Single-Arm, Phase IV Study.

BACKGROUND: Canagliflozin and metformin fixed-dose combination (CANA/MET FDC), an approved treatment for type 2 diabetes mellitus (T2DM) in India, effectively lowers glycated hemoglobin (HbA1c), promotes weight loss, and improves patient adherence. As a regulatory requirement, we aimed to evaluate the safety and efficacy of CANA/MET FDC in Indian patients with T2DM. RESEARCH DESIGN AND METHODS: This prospective, multicenter, open-label, single-arm, phase IV study included Indian patients with T2DM (aged 18-65 years) inadequately controlled on diet and exercise. Patients received CANA/MET (50/500 and 50/1000 mg) immediate-release (IR) FDC twice daily for 24 weeks. The primary endpoint was safety assessment, including adverse events (AEs) and serious AEs (SAEs). The secondary endpoint included a change in HbA1c from baseline to weeks 12 and 24. Descriptive statistics were used for all continuous safety variables and efficacy parameters. RESULTS: Of the 310 patients screened, 276 were enrolled. 114/274 (41.6%) patients had ≥1 treatment-emergent AE [treatment-emergent AEs (TEAEs), among which 29 (10.6%) were related to study intervention]. The most common TEAEs were dyslipidemia (4.7%), pyrexia (4.7%), genital infections (3.3%), hypoglycemia (3.3%), and urinary tract infections (2.6%). Three (1.1%) patients had serious TEAEs, and all cases were resolved. No deaths were reported. The mean change in HbA1c from baseline was -0.92 and -0.93% at weeks 12 and 24, respectively. CONCLUSION: The study demonstrates the safety and efficacy of CANA/MET FDC in Indian patients with T2DM, presenting a safe therapeutic option for diabetes management in India.

Correction: Altered Heart Rate Variability During Rest in Schizophrenia: A State Marker.

[This corrects the article DOI: 10.7759/cureus.44145.].

High-resolution full-field optical coherence tomography microscope for the evaluation of freshly excised skin specimens during Mohs surgery: A feasibility study.

Histopathology for tumor margin assessment is time-consuming and expensive. High-resolution full-field optical coherence tomography (FF-OCT) images fresh tissues rapidly at cellular resolution and potentially facilitates evaluation. Here, we define FF-OCT features of normal and neoplastic skin lesions in fresh ex vivo tissues and assess its diagnostic accuracy for malignancies. For this, normal and neoplastic tissues were obtained from Mohs surgery, imaged using FF-OCT, and their features were described. Two expert OCT readers conducted a blinded analysis to evaluate their diagnostic accuracies, using histopathology as the ground truth. A convolutional neural network was built to distinguish and outline normal structures and tumors. Of the 113 tissues imaged, 95 (84%) had a tumor (75 basal cell carcinomas [BCCs] and 17 squamous cell carcinomas [SCCs]). The average reader diagnostic accuracy was 88.1%, with a sensitivity of 93.7%, and a specificity of 58.3%. The artificial intelligence (AI) model achieved a diagnostic accuracy of 87.6 ± 5.9%, sensitivity of 93.2 ± 2.1%, and specificity of 81.2 ± 9.2%. A mean intersection-over-union of 60.3 ± 10.1% was achieved when delineating the nodular BCC from normal structures. Limitation of the study was the small sample size for all tumors, especially SCCs. However, based on our preliminary results, we envision FF-OCT to rapidly image fresh tissues, facilitating surgical margin assessment. AI algorithms can aid in automated tumor detection, enabling widespread adoption of this technique.

Temperature dependent structural properties of Mn1.90M0.10O3(M = Cr and Fe).

The polycrystalline samples of Mn1.90Cr0.10O3(MCO) and Mn1.90Fe0.10O3(MFO) have been investigated for their temperature dependent magnetic and structural properties. The Cr and Fe substitutions have significant effect on the magnetic and structural properties of Mn2O3. Like pristine Mn2O3, the Cr and Fe substituted samples MCO and MFO also exhibit two antiferromagnetic transitions; one at ∼77 K, ∼80 K, respectively and another at ∼40 K. Our room temperature synchrotron x-ray powder diffraction (SXRD) results confirm that both the MCO and MFO samples crystallize in cubic symmetry. The temperature dependent SXRD results demonstrate the cubic to orthorhombic structural transition for the studied samples. The pristine Mn2O3shows cubic to orthorhombic transition around 310 K, whereas this structural transition shifted towards lower temperature side with these substitutions i.e. around 240 K for MCO and 260 K for MFO. Interestingly, the centrosymmetricPcabto non-centrosymmetricPca21change in symmetry is also resolved at the ferroelectric ordering temperature for MCO.

GeneXpert Ultra in Urine Samples for Diagnosis of Extra-Pulmonary Tuberculosis.

Extra-pulmonary tuberculosis (EPTB) continues to be difficult to diagnose. Novel biomarkers in biological specimens offer promise. Detection of Mycobacterium tuberculosis (Mtb) DNA in urine could prove useful in diagnosis of EPTB, possibly due to disseminated disease or micro-abscesses reported in kidneys. The current study was designed to detect Mtb DNA in stored urine samples from patients with EPTB. Diagnosis of EPTB was reached using Microbiological Reference Standards (MRS) on samples from the disease site using WHO Recommended Diagnostics (WRD), [smear microscopy, liquid culture (MGIT-960)] and GX (molecular WRD, mWRD) and Comprehensive reference standards [CRS, clinical presentation, microbiological reference standards, radiology, histopathology]. GX-Ultra was performed on urine samples stored in -80oC deep freezer, retrospectively. Of 70 patients, 51 (72.9%) were classified as confirmed TB, 11 (15.7%) unconfirmed TB, and 8 (11.4%) unlikely TB. GX-Ultra in urine samples demonstrated sensitivity of 52.9% and specificity of 57.9% against MRS, and higher sensitivity of 56.5% and specificity of 100% against CRS. The sensitivity and specificity of GX-Ultra in urine was 53.6% and 75% for pus sample subset and 52.2% and 53.3% for fluid sample subset. Urine being non-invasive and easy to collect, detection of Mtb DNA using mWRD in urine samples is promising for diagnosis of EPTB.

Altered Heart Rate Variability During Rest in Schizophrenia: A State Marker.

BACKGROUND: Autonomic nervous system (ANS) imbalance has been reported in a number of psychiatric disorders such as depression, schizophrenia, panic disorder, etc. Autonomic dysfunction in schizophrenia has been associated with the symptoms and manifestation of psychosis. Heart rate variability (HRV) as a tool has been widely used to assess ANS activity and the effect of disease on the sympathovagal balance. Therefore, in the present study, HRV derived from electrocardiogram (ECG) lead II at rest was investigated in order to understand the changes in frequency domain measures in patients with schizophrenia and their first-degree relatives compared to healthy controls. METHODS: Twenty-five patients with schizophrenia, 24 first-degree relatives of patients, and 24 healthy controls (Diagnostic and Statistical Manual of Mental Disorders (DSM)-5; 18-45 years) were included in the study. HRV of the subjects was measured after five minutes of rest. ECG lead II was recorded for five minutes and HRV was analysed in the frequency domain: low frequency (LF), high frequency (HF), total power, and LF/HF ratio. HRV parameters and heart rate were statistically analysed for group comparisons using general linear model multivariate analysis. RESULTS: Patients had significantly higher minimum heart rate and lower HF (normalized units (nu)) compared to their first-degree relatives. A trend was observed in HF (nu) with the lowest in patients followed by healthy controls and first-degree relatives and LF/HF ratio was the highest in patients followed by healthy controls and first-degree relatives, although not statistically significant. No significant difference was found between first-degree relatives and healthy controls. CONCLUSION: The alteration of HRV in schizophrenia could be attributed to reduction in vagal tone and sympathetic dominance, which in turn could serve as state markers of schizophrenia.

Sex representation in neurodegenerative and psychiatric disorders' preclinical and clinical studies.

Many studies show the importance of biological sex for the onset, progression, and response to treatment in brain disorders. In line with these reports, health agencies have requested that all trials, both at the clinical and preclinical level, use a similar number of male and female subjects to correctly interpret the results. Despite these guidelines, many studies still tend to be unbalanced in the use of male and female subjects. In this review we consider three neurodegenerative disorders: Alzheimer's disease, Parkinson's disease, Amyotrophic lateral sclerosis, and three psychiatric disorders: Depression, Attention Deficit Hyperactivity Disorder, and Schizophrenia. These disorders were chosen because of their prevalence and their recognized sex-specific differences in onset, progression, and response to treatment. Alzheimer's disease and Depression demonstrate higher prevalence in females, whereas Parkinson's Disease, Amyotrophic lateral sclerosis, Attention Deficit Hyperactivity Disorder, and schizophrenia show higher prevalence in males. Results from preclinical and clinical studies examining each of these disorders revealed sex-specific differences in risk factors, diagnostic biomarkers, and treatment response and efficacy, suggesting a role for sex-specific therapies in neurodegenerative and neuropsychiatric disorders. However, the qualitative analysis of the percentage of males and females enrolled in clinical trials in the last two decades shows that for most of the disorders, there is still a sex bias in the patients' enrolment.

Novel Pyrazole-Based Transition Metal Complexes: Spectral, Photophysical, Thermal and Biological Studies.

A novel bioactive Schiff base (HL) named 3-methyl-1-phenyl-5-((5-nitrosalicylidene)amino)pyrazole was prepared by condensing 5-amino-3-methyl-1-phenylpyrazole with 5-nitrosalicyldehyde in methanol on a heating mantle in refluxing condition for 1 h. Some transition metal complexes of the ligand in (1 : 1) and (1 : 2) have also been prepared by condensing the metal acetate salt with the synthesized Schiff base. The Schiff base and metal complexes were characterized by different physiochemical techniques, i. e., 1 H-NMR, InfraRed, mass spectroscopy, elemental analysis, Ultraviolet-Visible, Cyclic voltammetry, electronic spectra and Electron spin resonance. The presence of water molecules in the complexes have been calculated with the help of thermogravimetric analysis. Kinetic parameters such that entropy change, enthalpy change and activation energy have been calculated with the help of Coats-Redfern equations. Fluorescence spectra showed enhancement in the fluorescence signal of the metal complexes. Square planar geometry for the copper complexes and octahedral geometry for the other metal complexes have been proposed with help of various methods. Biological activities of all the compounds have been carried out and the results disclosed that the metal complexes have high biological activity than the Schiff base having MIC value in the range 25-3.12 µg/mL and mycelial growth inhibition 60.82-96.98 %.

Quasispecies Nature of RNA Viruses: Lessons from the Past.

Viral quasispecies are distinct but closely related mutants formed by the disparity in viral genomes due to recombination, mutations, competition, and selection pressure. Theoretical derivation for the origin of a quasispecies is owed to the error-prone replication by polymerase and mutants of RNA replicators. Here, we briefly addressed the theoretical and mathematical origin of quasispecies and their dynamics. The impact of quasispecies for major salient human pathogens is reviewed. In the current global scenario, rapid changes in geographical landscapes favor the origin and selection of mutants. It comes as no surprise that a cauldron of mutants poses a significant risk to public health, capable of causing pandemics. Mutation rates in RNA viruses are magnitudes higher than in DNA organisms, explaining their enhanced virulence and evolvability. RNA viruses cause the most devastating pandemics; for example, members of the Orthomyxoviridae family caused the great influenza pandemic (1918 flu or Spanish flu), the SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) outbreak, and the human immunodeficiency viruses (HIV), lentiviruses of the Retroviridae family, caused worldwide devastation. Rapidly evolving RNA virus populations are a daunting challenge for the designing of effective control measures like vaccines. Developing awareness of the evolutionary dispositions of RNA viral mutant spectra and what influences their adaptation and virulence will help curtail outbreaks of past and future pathogens.

Cross-variant proof predictive vaccine design based on SARS-CoV-2 spike protein using immunoinformatics approach.

Background: Coronavirus Disease (COVID-19) is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 virus is evolving continuously. The omicron variant of SARS-CoV-2 has the highest mutation in its spike protein, thus making the presently available vaccine ineffective or reducing its efficiency. Furthermore, the majority of the vaccines are constructed using a spike protein sequence from wild-type SARS-CoV-2. This raises the possibility of the virus evolving to the point where the vaccine's effectiveness is completely lost, even after booster doses. The study aims to develop a predictive vaccine as well as the epitopes for the updating of the vaccine sequences of currently available vaccines. In this study, following the immunoinformatics approach, predictive vaccine construction was done with the help of epitopes present on spike proteins of wild-type, delta, and omicron variants that encompass the majority of variants and possible new variants that arise from the combination of circulating variants. Results: The vaccine that was constructed was stable and immunogenic. The vaccine was constructed with the help of 18 B-cell epitopes, 5 MHC class I epitopes, and 6 MHC class II epitopes. The epitope conservancy analysis suggests that the vaccine will work for the previously known variant of concern. The vaccine bound to TLR4, TLR2, B-cell receptor chains A and B, and ACE2 receptors with a z score of - 1.4, - 1.7, - 1.4, - 1.7, and - 1.4, respectively, with a cluster size of 121 highest for the ACE2 receptor and 46 lowest for B-cell receptor chain A. The C-ImmSim simulation results indicate that the vaccine is generating both humoral and cell-mediated responses at a sufficient level throughout the month upon injection of the vaccine as an antigen. Conclusion: The study's findings indicate that the vaccine was both stable and immunogenic, providing a sufficient level of immunity. Following experimental validation, the vaccine can be used, and the epitopes can be employed for therapeutic purposes such as antibody synthesis. Supplementary Information: The online version contains supplementary material available at 10.1186/s43088-023-00341-4.

Citrus Essential Oils in Aromatherapy: Therapeutic Effects and Mechanisms.

Citrus is one of the main fruit crops cultivated in tropical and subtropical regions worldwide. Approximately half (40-47%) of the fruit mass is inedible and discarded as waste after processing, which causes pollution to the environment. Essential oils (EOs) are aromatic compounds found in significant quantities in oil sacs or oil glands present in the leaves, flowers, and fruit peels (mainly the flavedo part). Citrus EO is a complex mixture of ~400 compounds and has been found to be useful in aromatic infusions for personal health care, perfumes, pharmaceuticals, color enhancers in foods and beverages, and aromatherapy. The citrus EOs possess a pleasant scent, and impart relaxing, calming, mood-uplifting, and cheer-enhancing effects. In aromatherapy, it is applied either in message oils or in diffusion sprays for homes and vehicle sittings. The diffusion creates a fresh feeling and enhances relaxation from stress and anxiety and helps uplifting mood and boosting emotional and physical energy. This review presents a comprehensive outlook on the composition, properties, characterization, and mechanism of action of the citrus EOs in various health-related issues, with a focus on its antioxidant properties.

Ecotoxicity assessment for environmental risk and consideration for assessing the impact of silver nanoparticles on soil earthworms.

Silver nanoparticles (AgNPs) are found in a range of commercial products due to their proven antibacterial properties. The unused silver nanoparticles (AgNPs) may make its way into the soil via biosolids that come from wastewater treatment or the effluent that comes from industrialisation processes, where it could be harmful to the organism that live in terrestrial ecosystems. In addition, silver ions are one of the most toxic forms of heavy metal released from dissolved silver nitrate (AgNO3) and AgNPs through dissolution or oxidation. The study examined the effect of engineered AgNPs, and AgNO3 on earthworms which are one of the most important bioindicator for determining toxicity in soil environment. Epigeic earthworm, Eudrilus eugeniae was exposed to soils spiked with equivalent concentrations of AgNPs or AgNO3 at 0, 10, 100, and 200 mg kg-1 in soil for 56 days of experiments. The survival and growth rate was recorded at 7th, 14th, 21st, 28th days and accumulation of Ag in earthworm tissue at 14th and 28th days, antioxidant enzymes at 28th days and reproduction at 56th days of experiment. Further, a short-term exposure of AgNPs and AgNO3 was conducted to observe avoidance behaviour after 48 h of exposure. The result indicated that survivability was relatively low on exposure of AgNO3 (83.3%) than AgNPs (86.7%) in 200 mg kg-1 spiked soils, besides the growth was inhibited in both AgNPs (3.68%) and AgNO3 (3.25%) at 28th days. The uptake of Ag from AgNO3 in the earthworm tissue was slightly higher than uptake of Ag from AgNPs and it showed concentration-dependent inhibitory effects on reproduction. In AgNO3 spiked soil, a high level of the Malondialdehyde (MDA) based lipid peroxidation and increased activity of antioxidant enzyme catalase (CAT) was observed than AgNPs spiked soil. Similarly, glutathione (GSH), a cofactor for GPx and GST enzymes, was lower in AgNO3-spiked soil than in AgNPs-spiked soil. In terms of avoidance behaviour, there was no discernible difference between the distribution of earthworms in AgNPs and AgNO3 after 48 h. The study found E. eugeniae exhibits concentration-dependent alterations in its competence to survive, antioxidant enzymes, and reproduction. AgNO3 was found to be more sensitive than AgNPs in the study. The research investigates the effect of AgNPs on earthworms in the soil ecosystem since this understanding is crucial for a comprehensive evaluation of AgNPs' environmental consequences.

Pharmacokinetic Similarity between Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 and Originator Insulin Aspart Mix 70/30 (NovoMix 30) in Indian Adults with Type 2 Diabetes: GEMELLI M Substudy.

Background: We compared the pharmacokinetic exposure, efficacy, safety and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (SARAsp-Mix) with its originator NovoMix® 30 insulin aspart mix (NN-Mix) in adults with type 2 diabetes. Methods: This was a randomized, open-label, parallel-group, substudy of the phase 3 GEMELLI M trial performed in three Indian centres. Totally 13 Indian participants previously treated with premix insulin received a single subcutaneous 0.3 U/kg dose of each treatment and underwent pharmacokinetic sampling for 16 h after dosing. Participants were then treated for 26 weeks as per the main GEMELLI M trial with efficacy, safety and immunogenicity compared between groups. Results: The extent of exposure (area under the plasma concentration-time curve and maximum insulin aspart concentration) to SAR341402 insulin aspart in SARAsp-Mix and to insulin aspart in NN-Mix was similar following single doses of the allocated treatment. After 26 weeks, the mean ± SD [median] change in HbA1c from baseline was similar in both treatment groups (SARAsp-Mix -0.38% ± 1.54 [-1.00%]; NN-Mix -0.18% ± 1.97 [-0.80%]). Other efficacy endpoints, insulin dosages, anti-insulin aspart antibody response, hypoglycemia and adverse events were similar between groups. Conclusions: Our results support the findings from previous studies, that SARAsp-Mix has a similar pharmacokinetic profile to NN-Mix and provides effective glycemic control with similar safety and immunogenicity profile in Indian adults with type 2 diabetes.

SARS-CoV-2 spike and nucleocapsid proteins fail to activate human dendritic cells or γδ T cells.

γδ T cells are thought to contribute to immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the mechanisms by which they are activated by the virus are unknown. Using flow cytometry, we investigated if the two most abundant viral structural proteins, spike and nucleocapsid, can activate human γδ T cell subsets, directly or in the presence of dendritic cells (DC). Both proteins failed to induce interferon-γ production by Vδ1 or Vδ2 T cells within fresh mononuclear cells or lines of expanded γδ T cells generated from healthy donors, but the same proteins stimulated CD3+ cells from COVID-19 patients. The nucleocapsid protein stimulated interleukin-12 production by DC and downstream interferon-γ production by co-cultured Vδ1 and Vδ2 T cells, but protease digestion and use of an alternative nucleocapsid preparation indicated that this activity was due to contaminating non-protein material. Thus, SARS-CoV-2 spike and nucleocapsid proteins do not have stimulatory activity for DC or γδ T cells. We propose that γδ T cell activation in COVID-19 patients is mediated by immune recognition of viral RNA or other structural proteins by γδ T cells, or by other immune cells, such as DC, that produce γδ T cell-stimulatory ligands or cytokines.

Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin.

INTRODUCTION: We compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (70% intermediate SAR341402 protamine and 30% rapid SAR341402 solution) (SARAsp-Mix) with its originator NovoMix 30 insulin aspart mix (NN-Mix) in adults with type 1 or type 2 diabetes switching from different premix insulin analogs. METHODS: This phase 3, randomized, open-label, multinational, 26-week trial (GEMELLI M) enrolled 402 participants with type 1 or type 2 diabetes. At randomization, participants switched from their prestudy premix insulin NovoMix 30 (n = 341) or Humalog Mix 25/Liprolog Mix 25 (n = 61) to equivalent (1:1) doses of either SARAsp-Mix or NN-Mix at least twice daily (1:1 randomization). In this subgroup analysis, efficacy measures [change in hemoglobin A1c (HbA1c), daily insulin dose], and safety outcomes [hypoglycemia incidence, adverse events (including hypersensitivity and injection site reactions), anti-insulin aspart antibodies] of SARAsp-Mix were compared with those of NN-Mix separately according to the participants' prestudy premix insulin. RESULTS: At week 26, change from baseline in HbA1c (primary efficacy endpoint) was similar between SARAsp-Mix and NN-Mix in those participants pretreated with NovoMix 30 [least squares (LS) mean difference 0.05%, 95% confidence interval (CI) -0.195% to 0.289%] or Humalog Mix 25/Liprolog Mix 25 (LS mean difference 0.28%, 95% CI -0.279% to 0.830%) (P value for treatment-by-subgroup interaction = 0.46). In both subgroups, safety outcomes, including immunogenicity, and changes in daily insulin doses were similar between treatments over 26 weeks. CONCLUSIONS: Efficacy, safety, and immunogenicity profiles of SARAsp-Mix are similar to NN-Mix over 26 weeks in adults with diabetes irrespective of prior type of premix insulin. TRIAL REGISTRATION: EudraCT number 2017-000092-84.

Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries.

INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in a real-world setting. METHODS: This 26-week, open-label, non-interventional study was conducted in Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp from antidiabetic treatments (including oral antidiabetic drugs, basal insulin, basal-bolus insulin, premix insulin, and glucagon-like peptide 1 receptor agonist) per local clinical practice. RESULTS: Compared with baseline, there was significant improvement in HbA1c at end of study (EOS, first visit within weeks 26-36; estimated change - 1.4% [95% CI - 1.51; - 1.29]; P < 0.0001 [primary outcome]). From baseline to EOS, there were significant reductions in fasting plasma glucose (- 2.7 mmol/L [95% CI - 2.98; - 2.46]; P < 0.0001), body weight (- 1.0 kg [95% CI - 1.51; - 0.52]; P < 0.0001), and basal insulin dose in insulin-experienced participants (- 2.3 units [95% CI - 3.51; - 1.01]; P < 0.001). The incidence rates of non-severe (overall and nocturnal) and severe hypoglycaemia decreased significantly (P < 0.001) between the period before baseline and before EOS. CONCLUSION: In adults with T2D, initiating or switching to IDegAsp from previous antidiabetic treatment was associated with improved glycaemic control, lower basal insulin dose (in insulin-experienced participants), and lower rates of hypoglycaemia. TRIAL REGISTRATION: Clinical trial registration NCT04042441.

Prevalence of Amoebiasis and Associated Complications in India: A Systematic Review.

PURPOSE: Intestinal protozoan parasites are responsible for diarrheal diseases causing significant morbidity and mortality. Entamoeba histolytica is the principle protozoan parasite associated with diarrheal infections. The infection is often associated with inaccessibility to clean drinking water and poor sanitary conditions in low- and middle-income countries including India. A comprehensive systematic review was performed to evaluate a reliable nationwide estimate for prevalence and geographic distribution of amoebiasis in India and the complications associated with it. METHODS: We used the PRISMA guidelines to perform a systematic review and meta-analysis of articles published between the year 2001-2020. Two English language databases PubMed and Web of Science were searched to achieve relevant studies. RESULTS: Initial searches resulted in 467 studies out of which 64 eligible articles involving data from 289,659 human subjects from 12 states and 4 union territories were included in the final analysis. Prevalence of amoebiasis ranged from 3-23% in asymptomatic population, 0.64-11% in symptomatic patients and 1-17.5% in HIV-infected patients. Highest prevalence was seen in Tamil Nadu, Andaman Nicobar Island and North East India. Extra intestinal invasion of Entamoeba histolytica leading to complications such as amoebic liver abscess, amoebic colitis, colonic perforation and ameboma were also reported. Such complications have the potential to increase healthcare burden and may prove to be fatal. CONCLUSION: Amoebiasis remains a significant public health issue in India responsible for diarrheal diseases causing significant morbidity and mortality. Entamoeba histolytica is the principle protozoan parasite associated with amoebiasis. Public health efforts should be directed towards its control and better diagnostic methods should be employed for distinguishing between pathogenic and non-pathogenic species of Entamoeba.