Unveiling Immunological Signatures and Predictors of Response to Immunosuppressive Therapy in Acquired Aplastic Anaemia".

Acquired Aplastic Anaemia (AA) often results from immune destruction of hematopoietic stem and progenitor cells. However, only 60-70% of patients with AA respond to immunosuppressive therapy (IST). There is lack of strong predictive marker for response to IST which can help therapy. Our study sought to pinpoint unique immune markers in AA patients and validate established predictors for response to IST. We enrolled 51 severe AA patients and analyzed 57 immunological parameters via flow cytometry. Additionally, we measured paroxysmal nocturnal hemoglobinuria (PNH) clone, telomere length, and thrombopoietin (TPO) levels prior to IST. After a 6-months follow-up, response was observed. Patients with AA had a distinct immunological signature characterized by absolute lymphopenia, skewed CD4/CD8 ratio with expansion of CD8 T cells with activated and senescent phenotype. Treg counts were reduced, while proportion of Treg A and B was comparable to controls. Treatment response was correlated with elevated Absolute Neutrophil Count (ANC), Absolute Reticulocyte Count (ARC), and reduced CD57+ CD8+ naive cells and B cell % before therapy. However, predictors like TPO, telomere length, and PNH did not emerge as indicators of treatment response. Identifying predictors for treatment response in AA is challenging due to abnormal haematopoiesis, genetic mutations, and treatment variables.

Ultrasound-acid modified Merremia vitifolia biomass for the biosorption of herbicide 2,4-D from aqueous solution.

In this work, a biosorbent was prepared by the ultrasound-acid treatment of Merremia vitifolia plant and tested for the removal of 2,4-dichlorophenoxyacetic acid (2,4-D), a phenoxy herbicide. Optimal values of five batch biosorption parameters namely stirring speed, contact time, biosorbent dosage, initial pH and initial adsorbate concentration were experimentally obtained in sequential manner for an enhanced biosorption capacity. The kinetics of the biosorption of 2,4-D were best described by the pseudo first order kinetic model (R2 = 0.99) and the biosorption equilibrium data were successfully fitted to the Langmuir adsorption isotherm (R2 = 0.99) with a maximum biosorption capacity of 66.93 mg g-1. The mechanism of biosorption was investigated using two intraparticle diffusion models (Weber and Boyd), Dubinin-Radushkevich isotherm model and electrostatic interactions. The presence of intraparticle and film diffusion limitations for the biosorption was confirmed along with the physical and chemical nature of the biosorption. The thermodynamic parameters of the biosorption were calculated using the equilibrium data obtained at four different temperatures. The entropy change for biosorption was found to be negative indicating the decreased randomness at the interface. Desorption studies were carried out using different solvents and the percentages of desorption were compared.

Land use change: A key ecological disturbance declines soil microbial biomass in dry tropical uplands.

Land use changes such as transformation of natural landscapes, forest degradation and increase in croplands due to human activities are considered amongst the most influential ecological disturbances affecting soil, ecosystems and environmental sustainability. The previous works from India are limited to show that soil disturbances influence abiotic and biotic factors along a rural-urban gradient. However, variations in soil microbial biomass (SMB) -C, -N and -P quantity due to land use changes at different soil depths across different land use types remain poorly understood on comparative ground. We investigated the impact of land use types on soil properties and SMB -C, -N and -P levels across different soil depths (0-10, 10-20 and 20-30 cm) in dry tropical uplands. Four land use types/covers (natural forest, mixed forest, savanna and agriculture land) were selected. The present study is based on two hypotheses: i) different land use types affect SMB levels in top surface soil (0-10 cm), but have less effects in deeper soil profiles (20-30 cm); and ii) SMB levels in top surface soil are highest in natural forest, followed by mixed forest and then savanna and agriculture lands. ANOVA showed significant differences in SMB values due to land use covers (P < 0.001), soil depths (P < 0.001) and land use types × soil depths interaction (P < 0.001). Although, there had no effect of land use types on SMB levels in deeper soil profiles (20-30 cm) but soil parameters (soil pH, soil moisture, soil temperature, total-N, C/N ratio and organic-C) significantly affect SMB levels in top surface (0-10 cm) soil. The study suggests that SMB may be considered as a key indicator of soil fertility index, while land use practices are a major cause for loss of microbial community composition/biomass in dry tropical upland soil.

Unravelling the Complex Interplay: Understanding Drug-induced Diseases and Teratogenicity from a Comprehensive Perspective.

Iatrogenic diseases, also referred to as drug-induced diseases (DIDs), represent a recognized yet inadequately investigated phenomenon that may result in enduring afflictions, hospital admissions, pharmacological interventions, protracted pharmaceutical reliance, and health complications. In the contemporary era of personalized medicine, it is imperative for prescribers to remain abreast of the dynamic advancements in the field of toxicology. Iatrogenic disorders may manifest as a result of medical interventions, including diagnostic procedures, therapeutic interventions, or preventative measures. Key factors to be taken into consideration encompass the patient's chronological age, dietary patterns, genetic predisposition, pre-existing medical conditions, diminished host response mechanisms, and pharmacological tolerance. Teratogenicity pertains to the prevalence of congenital anomalies and disorders resulting from exposure to teratogenic agents, environmental influences, and pharmacological interventions. The primary objective of this review is to provide individuals with comprehensive knowledge regarding the potential risks associated with iatrogenic diseases, thereby facilitating the prevention of unforeseen adverse outcomes.

Exploring nanocellulose's role in revolutionizing the pharmaceutical and biomedical fields.

The increasing global demand for eco-friendly products derived from natural resources has spurred intensive research into biomaterials. Among these materials, nanocellulose stands out as a highly efficient option, consisting of tightly packed cellulose fibrils derived from lignocellulosic biomass. Nanocellulose boasts a remarkable combination of attributes, including a high specific surface area, impressive mechanical strength, abundant hydroxyl groups for easy modification, as well as non-toxic, biodegradable, and environmentally friendly properties. Consequently, nanocellulose has been extensively studied for advanced applications. This paper provides a comprehensive overview of the various sources of nanocellulose derived from diverse natural sources and outlines the wide array of production methods available. Furthermore, it delves into the extensive utility of nanocellulose within the biomedical and pharmaceutical industries, shedding light on its potential role in these fields. Additionally, it highlights the significance of nanocellulose composites and their applications, while also addressing key challenges that must be overcome to enable widespread utilization of nanocellulose.

In Vitro Assessment of Antimicrobial Activity of Novel Fluoroquinolone, Levonadifloxacin (WCK 771) Against Multi-Drug-Resistant Clinical Isolates from Cancer Patients in India.

Introduction: Rapid increase in antimicrobial-resistance is leading to urgent need for newer broad-spectrum antimicrobials. Therefore, we have evaluated the antimicrobial résistance spectrum of India-discovered novel antibiotics (levonadifloxacin) against clinical isolates recovered from cancer patients. Materials and Methods: The study was conducted in the microbiology department, over a period of 1 year between May 2021 and June 2022 and 374 consecutive and nonduplicate Gram-positive (GPC) and MDR Gram Negative Bacteria (GNB) isolate were analyzed from 3,880 cancer patients in study. The identification and antimicrobial sensitivities of bacterial isolates were performed according to standard laboratory protocols by using automated identification system (VITEK-2-8.01; BioMérieux, Germany). The activity of levonadifloxacin and comparator antibiotics was evaluated using disk diffusion methods as per Clinical and Laboratory Standards Institute 2022 guidelines. Results: The mean age of the patients were 51.6 ± 14.59 years with male: female ratio of 1.2:1. The prevalence of GPC was 167 (44.65%) and MDR-GNB was 207 (55.34%). The most common GPC was Staphylococcus aureus; 97 (58.08%) followed by Enterococcus species 66 (39.52%). In GNB, Escherichia coli; 93 (44.92%) was the most common followed by Klebsiella pneumoniae; 45 (21.73%). Levonadifloxacin susceptibility was present in 98.7% methicillin-resistant S. aureus and 96% methicillin-susceptible S. aureus and 77.1% Enterococcus-species. Additionally, all the fluoroquinolones-resistant S. aureus isolates were susceptible to levonadifloxacin (WCK-771) except one isolate. Also, levonadifloxacin-(WCK-771) exhibits 100% susceptibility fluoroquinolone susceptible GNB, such as E. coli, K. pneumoniae, Pseudomonas species, and Acinetobacter species. Interestingly, all fluoroquinolones-resistant Salmonella species and Stenotrophomonas maltophilla exhibited 100% susceptibility to levonadifloxacin (WCK-771). Conclusion: Levonadifloxacin (WCK-771) possesses potent activity against all the MDR Gram-positive pathogens including the coverage of susceptible Enterobacterales and MDR S. maltophilla and Burkholderia cepacia suggesting its potential utility in the management of polymicrobial infections.

Serious Concern of Congenital Zika Syndrome (CZS) in India: A Narrative Review.

Congenital Zika syndrome (CZS) is a major concern in India and highlights the multifaceted challenges posed by the Zika virus (ZIKV). The alarming increase in CZS cases in India, a condition that has serious effects on both public health and newborns, has raised concerns. This review highlights the importance of raising concern and awareness and taking preventive measures by studying the epidemiology, clinical symptoms, and potential long-term consequences of CZS. The review also contributes to worldwide research and information sharing to improve the understanding and prevention of CZS. As India deals with the changing nature of CZS, this thorough review is an important tool for policymakers, health workers, and researchers to understand what is happening now, plan for what to do in the future, and work together as a team, using medical knowledge, community involvement, and study projects to protect newborns' health and reduce the public health impact of these syndromes.

Long non-coding RNA GRASLND links melanoma differentiation and interferon-gamma response.

Melanoma is a highly malignant tumor, that stands as the most lethal form of skin cancer and is characterized by notable phenotypic plasticity and intratumoral heterogeneity. Melanoma plasticity is involved in tumor growth, metastasis and therapy resistance. Long non-coding RNAs (lncRNAs) could influence plasticity due to their regulatory function. However, their role and mode of action are poorly studied. Here, we show a relevance of lncRNA GRASLND in melanoma differentiation and IFNγ signaling. GRASLND knockdown revealed switching of differentiated, melanocytic melanoma cells towards a dedifferentiated, slow-proliferating and highly-invasive cell state. Interestingly, GRASLND is overexpressed in differentiated melanomas and associated with poor prognosis. Accordingly, we found GRASLND expressed in immunological "cold" tumors and it negatively correlates with gene signatures of immune response activation. In line, silencing of GRASLND under IFNγ enhanced the expression of IFNγ-stimulated genes, including HLA-I antigen presentation, demonstrating suppressive activity of GRASLND on IFNγ signaling. Our findings demonstrate that in differentiated melanomas elevated expression of GRASLND interferes with anti-tumor effects of IFNγ, suggesting a role of GRASLND in tumor immune evasion.

CRISPR-inhibition screen for lncRNAs linked to melanoma growth and metastasis.

Melanoma being one of the most common and deadliest skin cancers, has been rising since the past decade. Patients at advanced stages of the disease have very poor prognoses, as opposed to at the earlier stages. Nowadays the standard-of-care of advanced melanoma is resection followed by immune checkpoint inhibition based immunotherapy. However, a substantial proportion of patients either do not respond or develop resistances. This underscores a need for novel approaches and therapeutic targets as well as a better understanding of the mechanisms of melanoma pathogenesis. Long non-coding RNAs (lncRNAs) comprise a poorly characterized class of functional players and promising targets in promoting malignancy. Certain lncRNAs have been identified to play integral roles in melanoma progression and drug resistances, however systematic screens to uncover novel functional lncRNAs are scarce. Here, we profile differentially expressed lncRNAs in patient derived short-term metastatic cultures and BRAF-MEK-inhibition resistant cells. We conduct a focused growth-related CRISPR-inhibition screen of overexpressed lncRNAs, validate and functionally characterize lncRNA hits with respect to cellular growth, invasive capacities and apoptosis in vitro as well as the transcriptomic impact of our lead candidate the novel lncRNA XLOC_030781. In sum, we extend the current knowledge of ncRNAs and their potential relevance on melanoma. Significance: Previously considered as transcriptional noise, lncRNAs have emerged as novel players in regulating many cellular aspects in health and disease including melanoma. However, the number and as well as the extent of functional significance of most lncRNAs remains elusive. We provide a comprehensive strategy to identify functionally relevant lncRNAs in melanoma by combining expression profiling with CRISPR-inhibition growths screens lowering the experimental effort. We also provide a larger resource of differentially expressed lncRNAs with potential implications in melanoma growth and invasion. Our results broaden the characterized of lncRNAs as potential targets for future therapeutic applications.

Key roles of C2/GAP domains in SYNGAP1-related pathophysiology.

Mutations in SYNGAP1 are a common genetic cause of intellectual disability (ID) and a risk factor for autism. SYNGAP1 encodes a synaptic GTPase-activating protein (GAP) that has both signaling and scaffolding roles. Most pathogenic variants of SYNGAP1 are predicted to result in haploinsufficiency. However, some affected individuals carry missense mutations in its calcium/lipid binding (C2) and GAP domains, suggesting that many clinical features result from loss of functions carried out by these domains. To test this hypothesis, we targeted the exons encoding the C2 and GAP domains of SYNGAP. Rats heterozygous for this deletion exhibit reduced exploration and fear extinction, altered social investigation, and spontaneous seizures-key phenotypes shared with Syngap heterozygous null rats. Together, these findings indicate that the reduction of SYNGAP C2/GAP domain function is a main feature of SYNGAP haploinsufficiency. This rat model provides an important system for the study of ID, autism, and epilepsy.

Study of Menstrual Patterns, Abnormalities, and Irregularities in Students.

Introduction One-third to one-half of females with primary dysmenorrhea are missing school or work at least once per cycle, and more frequently 5% to 14% of them. Dysmenorrhea is one of the most common gynecologic disorders among young girls and is the major cause of activity restriction and college absence. A direct link between primary menstrual abnormalities and chronic conditions such as obesity has been established, though the exact pathology behind it is yet unknown. Method A total of 420 female students between 18 and 25 years of age from various professional colleges in a metro city were included in the study. Semi-structured questionnaire was used. Students were examined for height and weight. Results History of dysmenorrhea was given by 82.6% students. Out of these, 30% had severe pain and required medication. Only 20% took professional help for the same. There was a high prevalence of dysmenorrhea in participants who ate food outside frequently. Prevalence of irregular menstruation was more (41.94%) in girls having junk food three to four times a week. Conclusion The prevalence of dysmenorrhea and premenstrual symptoms were much higher as compared to the other menstrual abnormalities. The study revealed a direct association between consumption of junk food and an increase in dysmenorrhea.

Effects of Ashwagandha ( Withania somnifera) standardized root extract on physical endurance and VO 2max in healthy adults performing resistance training: An eight-week, prospective, randomized, double-blind, placebo-controlled study.

Background: Ashwagandha is a well-known Ayurvedic herb used for youthful vigor and wellbeing. This study investigated the effects of 600 mg standardized root extract (>5% withanolides) of Ashwagandha ( Withania somnifera) on muscle size, strength and cardiorespiratory endurance following resistance training. Methods: In this eight-week, parallel-group, multicenter, randomized, double-blind, placebo-controlled clinical study, 80 healthy male and female participants aged 18-45 years, who engaged in regular physical activity were randomly allocated in a 1:1 ratio to receive Ashwagandha (AG, n=40) 300 mg capsules twice daily for eight weeks, or identical placebo (PB, n=40). Seven (3 AG, 4 PB) participants were excluded due to poor compliance. All participants conducted eight-week resistance training. Study outcomes included muscle strength (1RM bench press and leg extension), muscle size (circumference of arm, chest and upper thigh) and cardio-respiratory endurance (VO 2max) assessed at baseline and at eight weeks. Analysis of covariance (ANCOVA) was used to estimate adjusted differences based on sex, BMI and chest circumference at baseline. Results: AG caused greater improvement in bench press (males: p = 0.0084; females: p = 0.0005), leg press (males: p = 0.0049; females: p = 0.018) and endurance (males: p <0.0001; females: p <0.0001) as compared to PB. Also, greater improvements in muscle girth for arm, chest and thigh were seen in both male and female participants with AG. No adverse events were reported in the study. Conclusions: Eight weeks of AG root extract supplementation along with resistance training is effective in improving muscle strength, growth and endurance in both male and female participants. AG root extract could be a safer, effective and low-cost alternative for athletes to improve muscle endurance.

"Prevalence of chronic pain following resection of pelvic bone tumours: A single centre prospective observational survey".

Background: Hemipelvectomy is a major surgery most often performed for pelvic malignancy. These complex surgeries often involve dissection around major neurovascular bundle and resection of tumour being bone along with involved tissues. This may result in short and long term morbidities. There is very little literature about incidence of chronic pain after pelvic resections. We conducted a prospective study at a tertiary cancer hospital to assess the prevalence of chronic pain post hemipelvectomy. Method: This is a single centre prospective observational study conducted over 30 months. Pain scores were recorded using Brief pain inventory (BPI) and pain detect questionnaire. The quality of life was assessed using musculoskeletal tumour society (MSTS) score. Intra-operative details like extent of surgical resection, nerves spared, details of intra-operative and post-operative analgesia were retrieved from the patient files. Data were analysed using SPSS 21 version. Results: Neuropathic pain post hemipelvectomy was uncommon. The prevalence of mild to moderate somatic pain was around 30%. Functional limitation was minimal as assessed by BPI and MSTS score. A high incidence of numbness was seen to persist in and around the area of surgical incision (50%). Conclusion: This is first study to report the incidence of chronic pain post hemipelvectomy done for pelvic tumour resections. Despite the extensive nature of resection involved, there is a low prevalence of neuropathic pain in this population. However, incidence of persistent somatic pain is high and there is a need for further studies for evaluating the causality.

Imbalance of flight-freeze responses and their cellular correlates in the Nlgn3-/y rat model of autism.

BACKGROUND: Mutations in the postsynaptic transmembrane protein neuroligin-3 are highly correlative with autism spectrum disorders (ASDs) and intellectual disabilities (IDs). Fear learning is well studied in models of these disorders, however differences in fear response behaviours are often overlooked. We aim to examine fear behaviour and its cellular underpinnings in a rat model of ASD/ID lacking Nlgn3. METHODS: This study uses a range of behavioural tests to understand differences in fear response behaviour in Nlgn3-/y rats. Following this, we examined the physiological underpinnings of this in neurons of the periaqueductal grey (PAG), a midbrain area involved in flight-or-freeze responses. We used whole-cell patch-clamp recordings from ex vivo PAG slices, in addition to in vivo local-field potential recordings and electrical stimulation of the PAG in wildtype and Nlgn3-/y rats. We analysed behavioural data with two- and three-way ANOVAS and electrophysiological data with generalised linear mixed modelling (GLMM). RESULTS: We observed that, unlike the wildtype, Nlgn3-/y rats are more likely to response with flight rather than freezing in threatening situations. Electrophysiological findings were in agreement with these behavioural outcomes. We found in ex vivo slices from Nlgn3-/y rats that neurons in dorsal PAG (dPAG) showed intrinsic hyperexcitability compared to wildtype. Similarly, stimulating dPAG in vivo revealed that lower magnitudes sufficed to evoke flight behaviour in Nlgn3-/y than wildtype rats, indicating the functional impact of the increased cellular excitability. LIMITATIONS: Our findings do not examine what specific cell type in the PAG is likely responsible for these phenotypes. Furthermore, we have focussed on phenotypes in young adult animals, whilst the human condition associated with NLGN3 mutations appears during the first few years of life. CONCLUSIONS: We describe altered fear responses in Nlgn3-/y rats and provide evidence that this is the result of a circuit bias that predisposes flight over freeze responses. Additionally, we demonstrate the first link between PAG dysfunction and ASD/ID. This study provides new insight into potential pathophysiologies leading to anxiety disorders and changes to fear responses in individuals with ASD.

Randomized controlled trial comparing the efficacy of pectoral nerve block with general anesthesia alone in patients undergoing unilateral mastectomy.

This study was conducted to evaluate the efficacy of pectoral nerve block for post-operative analgesia in breast surgery patients. This double blinded, randomized controlled trial was conducted after Clinical Trials Registry-India registration. Sixty ASA grade I-II female patients undergoing unilateral modified radical mastectomy under general anesthesia, were recruited pre-operatively in two groups. PECS group (n  =  29) was given ipsilateral pectoral nerve block I & II while the CONTROL group (n  =  29) directly proceeded to surgery. Our primary outcome was comparison of immediate post-operative pain scores at rest and movement. The secondary outcomes were post-operative pain scores at 2, 4, 6, 12, 18, and 24 h, total intraoperative fentanyl consumption, time to rescue analgesia, post-operative nausea vomiting, and complications, if any. Categorical data was analyzed by using the chi-squared test or Fishers Exact test. Comparison of pain scores was analyzed by using the Independent sample t test. The immediate post-operative pain scores in two groups were comparable. The pain scores were also comparable at 4, 6, 12, and 24 h; but statistically significantly lower in PECS group at 2 and 18 h. The total intraoperative fentanyl consumption was also reduced in PECS group (P = 0.009). Only 9 patients in PECS group (796.5 min) as compared to 22 patients in CONTROL group (387.7 min) required rescue analgesia (P  =  0.001). Pectoral nerve block benefits patients undergoing mastectomy by achieving similar post-operative pain scores with decreased consumption of intraoperative and post-operative opioids. Registration. Clinical Trials Registry of India, (CTRI/2017/04/008289). ctri.nic.in.

A double-blind, randomized, placebo-controlled trial on the effect of Ashwagandha (Withania somnifera dunal.) root extract in improving cardiorespiratory endurance and recovery in healthy athletic adults.

ETHNOPHARMACOLOGICAL RELEVANCE: Ashwagandha is a reputed herb in traditional Ayurveda, used for various ailments and improving general well-being. Improved cardiorespiratory endurance can aid in attaining better physiological, metabolic, and functional abilities in humans. According to Ayurveda, Ashwagandha has such potential to improve human health. AIM OF THE STUDY: This study aimed to evaluate the efficacy and safety of Ashwagandha root extract in enhancing cardiorespiratory endurance in healthy athletic adults. MATERIALS AND METHODS: Fifty healthy athletic adults were selected randomly and equally allocated to Ashwagandha and placebo groups. The Ashwagandha group received 300 mg of Ashwagandha root extract capsules, twice daily, for 8-weeks. Cardiorespiratory endurance was assessed by measuring the maximum aerobic capacity (VO2 max). Estimation of stress management was done through Total Quality Recovery Scores (TQR), Recovery-Stress Questionnaire for Athletes (RESTQ), and Daily Analysis of Life Demands for Athletes (DALDA) questionnaires along with the antioxidant level measurement. RESULTS: At the end of the study, a statistically significant improvement in VO2 max outcome was observed in the Ashwagandha group when compared to the placebo group (P = 0.0074). The subjects in the Ashwagandha group also displayed a statistically significant increase at the end of the study when compared to the baseline (P < 0.0001). Significantly improved TQR scores were observed in the Ashwagandha group members compared to their placebo counterparts (P < 0.0001). DALDA questionnaire analysis in the Ashwagandha group was found statistically significant (P < 0.0001) compared to the placebo group. RESTQ assessment also yielded better outcomes, especially for fatigue recovery (P < 0.0001), lack of energy (P < 0.0001), and fitness analysis (P < 0.0001). The enhanced antioxidant level was significant (P < 0.0001) in the Ashwagandha group. CONCLUSION: The present findings suggest that Ashwagandha root extract can successfully enhance cardiorespiratory endurance and improve the quality of life in healthy athletic adults. No adverse events were reported by any of the subjects in this study.

Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers.

BACKGROUND: Ashwagandha (Withania somnifera) is a well-established and reputed herb in Ayurvedic medicine. It has been used as a "Rasayana" (rejuvenator), nootropic, and as a powerful natural adaptogen. The herb extract is extensively used for general wellbeing and in specific ailments. However, only a few studies have investigated the safety and tolerability of Ashwagandha in humans. This study evaluated the safety of Ashwagandha root extract consumption in healthy adults. METHODS: In this randomized, double-blind, placebo-controlled, and parallel-group study, 80 healthy participants (40 males, 40 females) were randomized in a 1:1 ratio to receive either Ashwagandha 300 mg or a placebo of the same dosage, twice daily, orally for 8 weeks. The study was conducted at MV Hospital, and King George Medical University, Lucknow, India. The primary safety outcomes considered were laboratory assessment of hematological parameters, serum biochemistry analysis including hepatotoxicity evaluation, and thyroid function parameters. The secondary outcomes of this study were the clinical adverse events and the vital parameters. The within and between the groups' datasets were compared using the Wilcoxon signed-rank test and the Mann Whitney U test, respectively. RESULTS: A detailed evaluation of the vital signs such as body weight, body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure, and Body Mass Index (BMI) were conducted for each participant at the baseline and the end of the study for treatment and placebo groups. Similarly, hematological and biochemical parameters were evaluated at the baseline and at the end of study. The outcome did not indicate any untoward effects in any of the treated volunteers. No statistically significant change or abnormality was observed in the considered parameters including thyroid hormonal profile in both the groups. No adverse events were reported by any of the participants in this study. CONCLUSIONS: Ashwagandha is being consumed since time immemorial following the Ayurvedic medicine practices. Modern science requires evidence of the safety and efficacy of the Ashwagandha extract before mass consumption for various health issues and as a supplement. The present study revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers. However, long term study and varying dosage ranges should be investigated in the future.

Unproven Stem Cell Therapies in India: Regulatory Challenges and Proposed Paths Forward.

Hundreds of clinics in India offer unproven stem cell therapies despite having remarkably stringent guidelines and regulations for fraudulent advertisements and clinical practice. We discuss the challenges with current regulations, how a recently proposed amendment may further legitimize unproven stem cell therapies, and discuss paths forward in a global context.

Regenerative medicine in India: trends and challenges in innovation and regulation.

The government of India has heavily promoted research and development in regenerative medicine together with domestic innovation and business development initiatives. Together, these promise a revolution in healthcare and public empowerment in India. Several national and transnational linkages have emerged to develop innovative capacity, most prominently in stem cell and cord blood banking, as well as in gene therapy, tissue engineering, biomaterials and 3D printing. However, challenges remain of achieving regulatory oversight, viable outputs and equitable impacts. Governance of private cord blood banking, nanomaterials and 3D bioprinting requires more attention. A robust social contract is also needed in healthcare more generally, so that participation in research and innovation in regenerative medicine is backed up by treatments widely accessible to all.