Background and aimAshwagandha, adaptogenic herb traditionally used to enhance resilience to stress and promote overall well-being. Although its safety at conventional doses is well established, evidence regarding the safety of higher doses in healthy adults remains limited. The present study aimed to evaluate the safety and tolerability of Ashwagandha root extract (ARE) administered at a dose of 2000 mg/day in healthy adults over 12 weeks.MethodsThis was a prospective, single-arm, non-comparative clinical study conducted in healthy adults aged 18–65 years. Participants received ARE 500 mg capsules (total daily dose of 2000 mg) orally for 12 weeks. Primary safety outcomes included laboratory evaluations of renal, hepatic, and thyroid parameters. Secondary safety outcomes included clinical assessment of adverse events and changes in quality of life assessed using the SF-36 questionnaire.ResultsOver 12 weeks, minor changes (p < 0.05) occurred in serum bilirubin, alkaline phosphatase, creatinine, transaminases, blood urea, and thyroid parameters in PP dataset (n = 124) who completed study. All values remained within reference ranges and were clinically insignificant, with most values slightly reduced except a small increase in alkaline phosphatase. No serious or clinically significant changes were noted. In ITT dataset (n = 145) most participants (85.5%) experienced no adverse events, with mild nausea being the most common at 5.5%. Quality of life (SF-36 scores) demonstrated improvement (p < 0.05) after 12 weeks in the SF-36 domains of physical functioning, role limitations due to physical health, social functioning, and pain.ConclusionHigh-dose Ashwagandha root extract (2000 mg/day) was well tolerated and demonstrated a favourable safety profile in healthy adults over 12 weeks.Trial registrationhttps://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODE3NTk=&Enc=&userName=, Identifier (CTRI/2023/04/051607).

Background:Polycystic Ovarian Syndrome (PCOS) is a hormonal disorder affecting women of reproductive age. It frequently causes hormonal imbalance, irregular menstrual cycle, and in some cases, infertility. For centuries, traditional herbs like Shatavari (Asparagus racemosus Willd.) have been used to support women's reproductive health, and some studies suggest it may help with PCOS symptoms. Thus, this study aimed to evaluate the safety and efficacy of standardized Shatavari root extract in women with PCOS. Methods:This prospective, randomized, double-blind, placebo-controlled trial was conducted on women aged 20-40 years for 12 weeks. Seventy participants were randomized into Shatavari root extract (SHT, n=35) and placebo (PL, n=35) groups. Sixty-six participants completed the full 12-week trial. The primary outcome was the change in ovarian and endometrial outcomes. Secondary outcomes were the change in Body Mass Index (BMI) and Perceived Stress Scale (PSS-10) scores. Assessments were performed at baseline, week 4, week 8, and week 12. Blood samples were collected at baseline and week 12 to estimate glycated hemoglobin (HbA1c), lipid profile, and serum insulin. The serum hormones, liver, renal, and thyroid functions were also assessed. For the safety assessment, adverse events were continuously monitored. Results:Baseline demographics and clinical parameters were comparable between groups. At 12 weeks, Ovarian volume did not differ significantly between groups (p= 0.254). SHT significantly reduced psychological stress (PSS score: -6.64 ± 3.99; p < 0.0001), decreased follicular count (p < 0.0001), and increased endometrial thickness (p = 0.028) compared to PL. No significant differences were observed in BMI, hormonal levels, or laboratory parameters. No serious adverse events occurred; mild to moderate events were reported in 11.4% (SHT) and 8.5% (PL) of participants, all manageable with standard therapy and not related to the intervention. Conclusion:Shatavari root extract oral administration can be a safe and effective potential intervention for women with PCOS. The study was registered with the Clinical Trials Registry of India (CTRI) under registration number CTRI/2024/10/074660 on October 3, 2024. Clinical Trial Registration:https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE0ODIy&Enc=&userName=, identifier CTRI/2024/10/074660.

Abstract Background: Modern life often leads to stress, manifesting physical symptoms like fatigue and headaches, as well as emotional effects such as anxiety and mood changes. Ashwagandha ( Withania somnifera ), a key medicinal plant in Indian Ayurveda, is renowned for its anti-stress and vitality-enhancing properties. This study aims to assess the efficacy and safety of Ashwagandha root extract in adults experiencing high stress and anxiety. Materials and Methods: This study is a prospective, randomized, multi-national, multi-center, double-blind, placebo-controlled trial designed to assess the safety and tolerability of Ashwagandha ( Withania somnifera ) root extract (ARE) in adults across different populations. The primary focus of the overall trial is on stress and anxiety reduction; this segment specifically investigates the safety and tolerability of ARE in an adult population. A total of 1000 subjects with anxiety and stress disorders were enrolled in the study. Conclusion: This study will provide compelling evidence that KSM-66 Ashwagandha root extract is a safe and well-tolerated intervention for reducing stress and managing anxiety in healthy adults.

Introduction: Completeness of Adverse Drug Reaction (ADR) reports is critical for effective pharmacovigilance. In India, different scoring tools are used to evaluate report quality, but little is known about their comparative performance in terms of time efficiency and scoring logic. Aim: To compare the two available completeness scoring tools- Tool I (Modified from National Coordination Centre (NCC) by Mahajan M et al.,) and Tool II {(A scale prepared by experts from one of the ADR Monitoring Centres (AMC)} for ADR forms with respect to the time required for assessment and the categorisation of completeness scores. Materials and Methods: The present comparative, cross over, open label pilot study was conducted at an AMC in Navi Mumbai, Maharashtra, India, between October 2024 to March 2025. This was a pilot study to check the feasibility so that a large, multicentric sample size could be conducted in near future. Thirty randomly selected ADR forms were independently evaluated by two professionals using two scoring tools: Tool I (Modified NCC by Mahajan M et al.,) and Tool II (Kuchya SK and Shrivastav S). A three day washout period was implemented. Completeness score distribution and time taken were analysed by using Mann-Whitney U test. Results: Tool I was more time-efficient than Tool II (62.4±8.5 vs 74.4±7.2 seconds; p<0.001). Using Tool I, 27 (90%) of reports were found to be >75% complete versus 25 (83.3%) using Tool II. Using Tool II, 5 ADR forms were in the 5 (50 75%) completeness category. The most frequent ADRs were rash 8 (26.6%) and itching 5 (16.6%), primarily associated with antimicrobials 12 (40%). Conclusion: Both tools were effective, but Tool I (Modified NCC) was significantly more time-efficient. The difference in scoring distribution highlights the need for a standardised tool to optimise ADR reporting practices.

Ashwagandha, a revered herb in Ayurvedic medicine for over 3000 years, is recognized for its potential benefits in regulating sleep and supporting overall vitality. This study evaluated the comparative effects of Ashwagandha root extract (ARE) and melatonin (MLT) on sleep quality in adults. In this prospective, randomized, double-blind, placebo-controlled trial, 200 men and women aged 18-50 years were randomized to receive ARE (300 mg twice daily; n = 50), MLT (3 mg/day; n = 50), a combination of ARE (600 mg/day) and MLT (3 mg/day; n = 50), or placebo (n = 50) for eight weeks. The primary outcome was the change in sleep onset latency (SOL) from baseline to week eight, measured by actigraphy. Secondary outcomes included actigraphy-based changes in total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE), as well as subjective measures such as the Pittsburgh Sleep Quality Index (PSQI) and the Hamilton Anxiety Scale (HAM-A). At week eight, SOL was significantly reduced across treatment groups, with the ARE-MLT (p < 0.0001) combination showing the greatest improvement. The combination group also demonstrated significant improvements in TST (p < 0.0001), WASO (p < 0.0001), and SE (p < 0.0001), whereas ARE and MLT monotherapy produced moderate but comparable benefits. Inferential analyses confirmed statistically significant improvements in objective and subjective sleep measures (p < 0.0001). Safety analyses indicated that mild adverse events occurred across all groups, with no clinically significant between-group differences. Overall, both Ashwagandha and melatonin improved sleep disturbances in adults, with combination therapy producing the most consistent and pronounced benefits.

Ashwagandha ( Withania somnifera ) has been recognized for enhancing physical strength, mental well-being, and overall vitality. Despite its long-standing use across generations, some clinical reports have noted occasional adverse events. This study compared the safety and tolerability of Ashwagandha Root Extract (ARE) in healthy adults. This was a prospective, multicenter, multinational, randomized, double-blinded, placebo-controlled study (n = 1002; 18 to 65 years). Participants with reported stress and anxiety were randomly assigned to receive either 600 mg/day (two divided doses) of ARE (n = 498) or a placebo (PL, n = 504) orally for 8 weeks. The primary outcome was the safety profile assessed through laboratory parameters and adverse events (AEs), while tolerability was assessed by the participants on a 7-point Likert scale of Global Assessment of Tolerability to Therapy. Demographic and baseline characteristics were similar between groups. No serious adverse events were reported; a total of 74 AEs (7.4%) were documented, with 46 events (9.2%) in the PL group and 28 events (5.6%) in the ARE group. The most common AEs include nausea (3.2% in PL vs. 2.0% in ARE), dry mouth (1.4% in both groups), and headache (2.2% in PL vs. 0.2% in ARE). Laboratory evaluations showed no significant changes in liver function tests, renal function markers, or hematological parameters between the ARE and PL groups. Both groups maintained normal ranges for key biomarkers, including aspartate aminotransferase, alanine aminotransferase, creatinine, and hemoglobin levels throughout the study duration. Tolerability ratings showed no statistically significant difference between the groups (p = 0.487), and most of the participants rated the ARE therapy as "Good" or "Excellent." ARE is well-tolerated and safe in adults with stress and anxiety. These results support the use of Ashwagandha root extract as a viable non-pharmacological treatment, warranting further exploration of its long-term effects in diverse populations.

Purpose:Women's sexual health is affected by physical, psychological, and emotional aspects. In Ayurvedic medicine, Shatavari (Asparagus racemosus) is traditionally classified as a Rasayana known to promote reproductive health and overall well-being in women. The present study aims to evaluate the safety and efficacy of a standardized Shatavari root extract (SHT) in improving women's sexual health. Patients and Methods:A prospective, randomized, double-blinded, placebo-controlled, three-armed study was conducted over 8 weeks with 135 women participants. Participants were randomly assigned to receive either SHT, Shatavari with Ashwagandha root extracts (SHT-ARE), or a placebo (PL). The primary outcome was assessed using the Female Sexual Function Index (FSFI). Secondary outcomes were measured by Satisfying Sexual Events (SSEs), Female Sexual Distress Scale (FSDS), Profile of Mood States (POMS), Oxford Happiness Questionnaire (OHQ), and Pittsburgh Sleep Quality Index (PSQI), which were used for efficacy analysis. The safety parameters were monitored by treatment-emergent adverse events and changes in liver, thyroid, and renal function markers. Results:At post-intervention (8 weeks), the SHT-ARE group demonstrated improvements in FSFI Arousal (P = 0.041), Lubrication (P = 0.027), Orgasm (P = 0.031), and Total FSFI (P = 0.005) scores compared to the PL group, whereas the SHT group showed improvements in only Total FSFI (P = 0.025) and Satisfaction (P < 0.0001). The number of sexual intercourses between SHT-ARE and PL was increased significantly (P = 0.001), while FSDS scores showed a significant difference in both SHT-ARE (P < 0.0001) and SHT (P = 0.008) when compared to the PL group. Improved OHQ scores in the SHT-ARE group (P < 0.0001) signify greater happiness. Reduced POMS values (SHT-ARE) specified reductions in Tension, Anger, Depression, Fatigue, Esteem-related affect, Confusion, and Total score (P < 0.0001) compared to PL. The SHT-ARE group at week 8 represented no significant differences in PSQI scores, except for Sleep efficiency (P = 0.045) compared to PL. All reported events were mild and resolved with no intervention. Conclusion:Shatavari root extract is considered a safe, effective, and well-tolerated treatment for improving women's sexual health and well-being. In addition, it shows an additive effect in combination with Ashwagandha.

Adverse drug reactions (ADRs) are an important consideration in clinical practice, particularly in patients with complex conditions such as allergic bronchopulmonary aspergillosis – Sero-positive (ABPA-S). Somatoform disorders are psychological conditions where physical symptoms lack a medical cause, causing signicant distress and requiring a multidisciplinary treatment approach. Allergic Bronchopulmonary Aspergillosis (ABPA) sero-positive is a hypersensitivity reaction to Aspergillus fumigatus, a common environmental fungus, seen primarily in patients with asthma or cystic brosis, characterized by elevated serum IgE and positive Aspergillus-specic IgE and/or IgG antibodies. This case report details somatoform disorder presenting as serious adverse drug reaction to a combination of Ceftazidime and Tazobactam in a patient with ABPA as atypical presentation. The case underscores the importance of pharmacovigilance in drug administration and highlights the utility of clinical scoring systems in ADR evaluation.

Introduction In the evolving landscape of modern medicine, the role of medical devices is becoming increasingly central, especially in orthopedic surgery. From implants and prosthetics to advanced diagnostic tools, orthopedic surgeons rely heavily on an array of medical devices to deliver high-quality care. However, with the rising complexity of these devices comes the risk of adverse events that can potentially harm patients. This is where Materiovigilance – the systematic monitoring and reporting of adverse events related to medical devices – plays a critical role. Launched in 2015 under the guidance of the Indian Health Ministry, the Materiovigilance Programme of India (MvPI) has been designed to ensure that medical devices used in healthcare are safe, effective, and monitored continuously for any adverse events. Orthopedic surgeons, who work closely with a vast array of implants, joint replacement devices, and surgical instruments, are uniquely positioned to contribute to and benefit from the MvPI. Their engagement in the program is not only crucial for patient safety but also for enhancing the quality of care across the field of orthopedics. Why Materiovigilance Matters in Orthopedics Orthopedic surgeries often involve the use of sophisticated and high-stake medical devices, such as joint replacements, plates, screws, and spinal implants. These devices, while designed to improve mobility and quality of life, come with their own set of risks. Failures, malfunctions, or unexpected complications with these devices can lead to severe patient outcomes, including revision surgeries, infections, or even permanent disability. It is imperative for orthopedic surgeons to be vigilant about such issues. The Materiovigilance Program allows surgeons to report any adverse events associated with the use of these medical devices, ensuring that potential issues are documented, analyzed, and corrected in the broader system. This proactive approach allows manufacturers to rectify design flaws, alert the medical community about potential risks, and ultimately help to prevent the recurrence of similar incidents. The Role of Orthopedic Surgeons Orthopedic surgeons play a pivotal role in the successful implementation of the MvPI. Their familiarity with the devices used during procedures, coupled with their insights into patient outcomes, makes them key contributors to materiovigilance efforts. By actively participating in reporting adverse events, orthopedic surgeons help build a robust database that can identify patterns of device failure, leading to enhanced patient safety protocols and improved device design. Despite the clear benefits, however, there remains a significant gap in the awareness and practice of materiovigilance among healthcare professionals in India. Studies have shown that a lack of awareness, insufficient training, and misconceptions about the reporting process contribute to underreporting of adverse events related to medical devices. For orthopedic surgeons, who often manage complex cases involving multiple devices, this lack of reporting represents a missed opportunity to enhance patient safety. Strengthening Materiovigilance in Orthopedics To bridge this gap, concerted efforts are needed to raise awareness of the MvPI among orthopedic professionals. Continuing Medical Education programs, workshops, and training sessions focused on materiovigilance should become integral to the education and professional development of orthopedic surgeons. These initiatives can demystify the reporting process, emphasize its importance, and encourage surgeons to contribute actively. Furthermore, hospitals and healthcare institutions need to create a culture that encourages reporting, without fear of repercussions or legal action. Surgeons should feel confident that their reports will be used to improve device safety, not to assign blame. Transparency, collaboration, and a shared commitment to patient safety will be key to making materiovigilance a routine part of orthopedic practice. Conclusion: A Call to Action For orthopedic surgeons, the MvPI is more than just a regulatory requirement – it is a tool to safeguard their patients and improve the quality of care. By actively participating in this program, surgeons can help to ensure that the medical devices they rely on are safe, effective, and continuously improved. As orthopedic surgery continues to advance, with newer and more innovative devices entering the market, the role of materiovigilance will only grow in importance. Orthopedic surgeons must lead the charge in adopting this practice, contributing to a safer and more reliable healthcare environment for all. The future of orthopedic care depends not only on the skills of the surgeon but also on the collective responsibility to monitor and improve the tools they use. In embracing the principles of materiovigilance, orthopedic surgeons have the opportunity to not only enhance patient safety but also contribute to the long-term success and innovation in their field.

Ashwagandha, an adaptogen, is an important herb of Ayurveda used as a Rasayana for its various health benefits. This prospective, multi-center, observational clinical study evaluates the safety (clinical and laboratory) of a standardized Ashwagandha Root Extract (ARE) on long-term administration over 12 months. Male and female adults (N = 191) aged between 18 and 65 years were included in the study. Clinical assessments were done at baseline, followed by monthly for 12 months, whereas laboratory and other study assessments were done at baseline, 6 and 12 months. The primary outcome was the clinical adverse events reported by the patients, whereas secondary outcomes were Clinical Global Impression-Improvement scale (CGI-I), health-related Short Form-12 Quality of Life (SF-12 QoL), and laboratory estimations of serum for cortisol, hepatic, renal, and thyroid function. ARE administration for 12 months reported 18 mild adverse events, which were resolved without intervention. The study reported no clinical significant changes in serum alanine transaminases (baseline: 31.31 ± 9.28 IU/L, end of study: 33.68 ± 6.80 IU/L), aspartate transaminases (baseline: 30.61 ± 7.18 IU/L, end of study: 29.02 ± 4.63 IU/L). Serum cortisol levels decreased significantly (p < 0.001), while lipid profile and plasma glucose levels remained unaffected. Serum testosterone (free and total) significantly increased (p < 0.05). SF-12 scores demonstrated significant improvements at 12 months (p < 0.001), indicating enhanced health-related quality of life. CGI assessment indicated overall improvement in 68.7% of patients, particularly notable in those aged ≥ 50 years. This study validates the long-term safety of ARE use over 12 months. Trial Registration: ClinicalTrials.gov identifier: CTRI/2022/10/046180; NCT06244147.

Partial caries removal reduces the risk of pulp exposure while preserving the tooth structure that is otherwise unnecessarily lost during the cavity preparation. Liners are applied on the dentinal floors to induce the formation of tertiary dentin that effectively blocks the stimuli from reaching the pulp. The present systematic review was conducted to evaluate the effect of liners on pulp vitality after partial caries removal in permanent teeth. This systematic review followed the resources of evidence-based medicine such as the Cochrane Handbook and was conducted as per PRISMA guidelines. The PICOS strategy was designed and included patients with deep carious lesions in permanent teeth with and without application of liner after partial caries removal, with pulp vitality assessment at one year. After applying the inclusion and exclusion criteria, four articles were selected after an initial list of 750 articles. The results of meta-analysis indicated that there was no statistically significant difference between intervention and control groups (OR=1.440; 95% CL= 0.812 to 2.552; P=0.212). According to the Risk of Bias 2 tool, all four studies were classified as "low risk." Certainty of evidence was moderate as per GRADE (Grading of Recommendations, Assessment, Development, and Evaluations). Partial caries removal with and without a liner had similar outcomes on pulp vitality at one year follow up. Role of a liner remains controversial in partial caries removal therapy. On the basis of this systematic review and meta-analysis, it may be inferred that treatment success, as defined by continued pulp vitality, is independent of liner application.

BACKGROUND:Ashwagandha, a traditional Indian Ayurvedic remedy, an adaptogen, may improve sexual dysfunction in men and women. OBJECTIVE:This 8-week prospective, double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of Ashwagandha Root Extract (ARE) on improving sexual health in healthy adult men. METHOD:A total of 100 healthy men aged 30-50 years were randomly assigned to receive ARE 300 mg twice daily (n = 50), or identical placebo (n = 50) in a 1:1 ratio for 8 weeks. Study assessments such as Satisfying Sexual Events (SSEs), the Sexual Desire Inventory (SDI-2), the International Index of Erectile Function (IIEF) score, semen parameters and the Quality of Life (QOL) were done using the SF-12 tool at baseline, week 2, week 4, and week 8. Three participants from ARE and four participants from the placebo group were excluded due to follow-up loss. The efficacy analyses were done on Per-Protocol (PP) dataset of 93, whereas safety analyses were done on all 100 participants. RESULTS:Significant improvements were observed with ARE for semen volume (p = 0.005), sperm number (p = 0.006), sperm concentration (p = 0.007), and sperm morphology (p = 0.007). The improvement in scores was better with ARE for SDI-2 (p < 0.05), orgasm and sexual desire domains of IIEF (p < 0.05), and SF-12 (p < 0.0001). No adverse events were reported in the study. CONCLUSION:Ashwagandha improved the orgasmic function, sexual desire and overall sexual satisfaction with the 8-week of oral administration. It was well tolerated as it showed no significant changes in hepatic and renal parameters in blood.

The relationship between excess body weight and stress significantly impacts overall health. The current study evaluated the efficacy and safety of Ashwagandha (Withania somnifera) root extract (ARE) in altering stress biomarkers and its role in weight management. In this prospective, randomized, double-blind, placebo-controlled study, 100 participants (age: 19-65 years) were randomized to receive either ARE 300 mg twice daily (n = 50) or an identical placebo (PL, n = 50) for 24 weeks. The primary efficacy endpoints were changes in body weight and body mass index (BMI). Secondary endpoints included evaluation of stress (Perceived Stress Scale, PSS), quality of life (Short Form-12 Quality of Life Scale), subjective satisfaction (Subjective Satisfaction Scale, SSS), and food cravings (Food Cravings Questionnaire-Trait, FCQ-T). Clinical safety was assessed based on treatment-emergent adverse events (TEAEs) and laboratory parameters, including complete blood count, renal function tests, liver function tests, lipid profile, thyroid function tests, and glycemic parameters (plasma glucose and glycated hemoglobin). Efficacy was analyzed in 91 patients. ARE administration resulted in a significant reduction in body weight (-8.46 ± 3.86 kg; P < 0.0001) and BMI (-3.31 ± 1.57 kg/m2; P < 0.0001) compared to the PL (-2.41 ± 2.07 kg and -0.93 ± 0.79 kg/m2 for body weight and BMI, respectively). Compared with PL, ARE showed significant improvements (P < 0.05) in PSS, SF-12, SSS, and FCQ-T scores. A total of seven participants with ARE and six with PL reported mild adverse events (nausea, abdominal pain, and drowsiness), which were resolved without any intervention. Ashwagandha root extract may offer a safe and beneficial approach for stress reduction and weight management.

Introduction Adverse drug reactions (ADRs) are a major cause of morbidity, mortality, and healthcare burden worldwide. Underreporting of ADRs is a major barrier to drug safety, making early sensitization of healthcare students through pharmacovigilance programmes essential. Sensitization during undergraduate training of medical and para-medical students is therefore important to instill early awareness, bridge knowledge gaps, and encourage proactive participation in ADR reporting. The objective of this study was to evaluate the knowledge, attitude, and impact of a pharmacovigilance sensitization session among medical and paramedical students. Methods A pre-post interventional study using a validated knowledge-attitude questionnaire was conducted during the fourth National Pharmacovigilance Week (2024) at a tertiary care teaching hospital. Participants (medical, Ayurveda, and paramedical students) completed pre- and post-test surveys. Data were analyzed using descriptive statistics and chi-square tests. Data was analysed with the help of IBM SPSS Statistics for macOS, Version 29.0 (IBM Corp., Armonk, NY, USA). Results A total of 259 students participated (130 medical/ayurveda and 129 paramedical) in the study. Pre-test knowledge was significantly higher in medical students regarding ADR reporting (n=107, 82.5% vs. n=81, 62.8%; p=0.0007) and ADR forms (n=80, 62% vs. n=63, 48.8%; p=0.0536). Post intervention, both groups showed significant improvements, especially in recognizing pharmacovigilance terminology (n=71, 87.7% and n=57, 66.3%) and ADR reporting forms (n=49, 98% and n=52, 78.8%). Attitudes also improved, with medical students consistently demonstrating more positive responses. Conclusion Sensitization sessions during the National Pharmacovigilance Week significantly improved knowledge and attitudes toward pharmacovigilance and ADR reporting among future healthcare providers. Regular interventions are recommended to sustain awareness.

This prospective, randomized, placebo-controlled study assessed the effects of Ashwagandha root extract (ARE) on cognition, energy, and mood in adults with self-reported cognitive and energy problems. Healthy subjects aged 30-75 years were randomized to receive ashwagandha (Withania somnifera) root extract (ARE) 600 mg/day (n = 60)/identical placebo (n = 60) orally for 8 weeks. Cognitive function was assessed at baseline and week 8 using a Computerized Mental Performance Assessment System (COMPASS). Secondary outcomes were Profile of Mood States Abbreviated Version (POMS-A), Mental Fatigue Scale (MFS) and Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) for effects on mood, mental fatigue and executive function, respectively, assessed at baseline, week 4 and 8. Greater improvement (p < .05) from baseline scores were seen with ARE as against placebo for COMPASS items episodic memory, working memory and accuracy of attention. ARE also improved the POMS-A, MFS and BRIEF-A scores from baseline suggesting an improvement in mood, vigor, and an increase in the executive functioning respectively with ARE. The herb was well tolerated and had a good patient compliance with no serious adverse events reported in either of the groups. This study suggests that a dose of 600 mg a day can improve cognition, energy, and mood in adults with self-reported cognitive and energy problems.

Introduction: Materiovigilance is an organized method for locating, obtaining, recording, and evaluating any unfavorable occurrences associated with medical devices to protect a patient’s health by preventing recurrences. Recent advancements in science and technology have led to a significant expansion in the role of medical devices in the healthcare delivery system. This questionnaire-based cross-sectional study was conducted among physicians and nurses in a teaching hospital that offers tertiary care and is part of the MvPI MDAE reporting system. Case report: Among the participants, the worst performers were junior nurses, with 66.7% unaware of the term materiovigilance itself, and the best performers were professors, at 73.5%. Participants self-rated their knowledge, and 31.0% considered it average regarding the subject. However, only 53% of respondents were aware of MvPI systems in their institution, and 60.5% were aware of the reporting process. Conclusion: This study shows that our tertiary care teaching institute’s medical practitioners lack sufficient materiovigilance knowledge. A campaign of ongoing materiovigilance awareness among healthcare practitioners and nurses, however, would enhance their understanding and inspire them to report MDAEs.

Ashwagandha ( Withania somnifera) is a popular herb in Ayurveda, the traditional medicine system in India. It is known to exert stress-mitigating properties and has been extensively studied for its safety and efficacy in various disorders. This in vivo study assessed the effects of Ashwagandha root extract (ARE) on stress in rats. The anxiolytic and antidepressant effects of ARE were assessed using the elevated plus maze test, sucrose preference test, and forced swim test. The rats were divided into the following groups: control group (no disease), disease control group (no treatment), standardized ARE group (test; ARE administered in doses of 27, 54, and 108 mg/kg body weight), and fluoxetine group (active control). Biochemical parameters in the serum [monoamine oxidase (MAO)-A, MAO-B, serotonin, cortisol, adrenocorticotropic hormone (ACTH), corticotropin-releasing hormone (CRH), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha, and brain-derived neurotrophic factor (BDNF)] and brain tissue (serotonin) were estimated at the end of 36 days to understand the potential mechanism behind the anxiolytic and antidepressant effects of ARE. The behavior test results indicated significant improvement in anxiety and depression-like behavior with ARE treatment in a rat model exposed to a validated protocol of chronic variable stress. The results of biochemical analyses revealed a significant increase in serotonin and BDNF levels and a decrease in CRH, ACTH, and cortisol levels. The inflammatory markers IL-6 and TNF-alpha were also significantly reduced with ARE treatment. ARE demonstrated notable effects on anxiety and depression markers in rats, indicating its potential as a prophylactic and therapeutic agent.

Background and Objective:Yogic breathing helps in reduction of stress and strain in the body. Right and left nostril breathings (RNB and LNB, respectively) have different effects on cardiorespiratory parameters. The study was performed to examine the effect of RNB exercise on cardiorespiratory parameters and reaction time in young, healthy human volunteers. Materials and Methods:In this prospective, interventional study, 110 young healthy volunteers underwent systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate (PR), respiratory rate (RR), vital capacity (VC), peak expiratory flow rate (PEFR), and reaction time (RT) examination before and after 2 weeks of performing 45 min of RNB exercise daily. Results:There was notable increment in SBP (113.39 ± 17.72 vs. 117.74 ± 10.83 mmHg, P = 0.002) and DBP (67.64 ± 10.32 vs. 71.27 ± 8.68 mmHg, P = 0.002). PR increased nonsignificantly (86.44 ± 12.65/min vs. 87.32 ± 13.43/min, P = 0.476). Significant decrease in RR (14.40 ± 2.48/min vs. 12.31 ± 2.23/min, P < 0.0001) was observed. VC (3.57 ± 0.57 vs. 3.82 ± 0.55 L/min, P < 0.0001) and PEFR (441.36 ± 50.22 vs. 468.91 ± 53.66 L/min, P < 0.0001) also increased significantly. Substantial reduction in auditory reaction time (ART) (165.58 ± 32.18 vs. 147.42 ± 23.39 ms, P < 0.0001) and visual reaction time (VRT) (191.04 ± 37.94 vs. 165.86 ± 28.74 ms, P < 0.0001) was seen. After engaging in cardiorespiratory exercise, the maximal heart rate (MHR) remained unchanged (P = 0.929). Conclusion:RNB results in increase in blood pressure, heart rate, VC, and PEFR and decrease in ART and VRT. Further studies in patients with cardiorespiratory diseases are necessary to understand its clinical utility.

Glutathione is one of the non-enzymatic antioxidants that is also involved in regulation of cellular proliferation and apoptosis. The application of Glutathione for skin lightening and depigmentation in dermatology started after discovery of its anti-melanogenic properties. There is still a lack of evidence regarding its patient population, dosage schedule, and safety on long-term use. The objective of this study is to analyze the usage pattern of Glutathione from dermatologists in India based on their clinical experience. Questionnaire-based cross-sectional study conducted amongst dermatologists to understand indications, administration, safety, and adverse events associated with Glutathione therapy. Data entry was done in Microsoft Excel and descriptive statistics was applied. Seventy-one responses were collected with the average experience of dermatologists being 5.24 + 7.32 years. 52.11% of these dermatologists routinely prescribe Glutathione therapy. The most common use is skin lightening given through the oral route. The preferred dose for oral route is 250mg given twice daily empty stomach for 4 weeks, topical route is 2% (w/w) applied once daily for 10 weeks, and intravenous route is 1200mg injection given weekly over 30 minutes. Only 3 out of 37 prescribing doctors have seen side effects. 54% of dermatologists feel that there is insufficient safety data available for this therapy. This study shows the current practices of Glutathione therapy by dermatologists while also pointing to the need for more studies to be done with a larger sample size for a longer duration so that the use is standardized with improved safety.

Withania somnifera (ashwagandha, WS) is widely used in traditional Indian Ayurvedic medicine. Studies indicate ashwagandha possesses antioxidant, anxiolytic, memory enhancing, antiparkinsonian, anti-venom, anti-inflammatory and antitumor properties. Present study evaluated the sub-acute toxicity of repeated dose administration of Ashwagandha root extract in wistar rats.