Effect of an ashwagandha (Withania Somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study.

BACKGROUND: Perimenopause is the period during which many physiological changes mark the transition into the final menstrual period of a woman and these changes are associated with climacteric symptoms. OBJECTIVES: This study aimed to assess the efficacy and tolerability of an Ashwagandha root extract on the climacteric symptoms, quality of life (QoL), and hormonal parameters in perimenopausal women. MATERIALS AND METHODS: In this 8-week, randomized, double-blind, placebo-controlled study, 100 women with climacteric symptoms were randomly allocated to take either a placebo or 300 mg of an Ashwagandha root extract twice daily. Outcomes were measured using the menopause rating scale (MRS), menopause-specific QoL (MENQoL), hot flash score, and hormonal changes in estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone. RESULTS: Among 100 participants enrolled, 91 participants completed the study. In comparison with the placebo, ashwagandha supplementation was associated with a statistically significant reduction in total MRS score (p < 0.0001), reflected by significant reductions in the psychological (p = 0.0003), somato-vegetative (p = 0.0152), and urogenital (p < 0.0001) domains. Ashwagandha intake demonstrated a statistically significant reduction in total MENQoL scores (p < 0.0001) and was also associated with a statistically significant increase in serum estradiol (p < 0.0001) and a significant reduction in serum FSH (p < 0.0001) and serum LH (p < 0.05) compared with the placebo. There was no significant between the group differences in the serum testosterone level. CONCLUSION: These findings suggest that ashwagandha root extract can be a safe and effective option to relieve mild to moderate climacteric symptoms during perimenopause in women.

Mutagenicity and safety evaluation of Ashwagandha (Withania somnifera) root aqueous extract in different models.

Withania somnifera (Ashwagandha) also called as Indian ginseng, a revered herb from Indian traditional system of medicine is a rejuvenator and tonic (Rasayana) used for its varied benefits. The roots of ashwagandha exhibit properties like anti-inflammatory, aphrodisiac, anthelmintic, astringent, diuretic, stimulant and thermogenic. However, data of ashwagandha on its mutagenic effects are lacking. In the present study, in-vitro genotoxicity tests were used to evaluate the mutagenic potential of Ashwagandha Root Extract (ARE). Concentrations of 0.156 to 5.00 mg/plate ARE were used for conducting Bacterial reverse mutation test (BRMT). For chromosome aberration (CA) test ARE was used in concentrations of 0.25 to 2.00 mg/ml, and for micronucleus (MN) tests ARE concentrations of 500/1000/2000 mg/kg were used. Acute oral toxicity was conducted in Wistar rats (n = 25) as per the OECD guideline (#423) with doses of 500/1000/2000 mg/kg body weight in male Swiss albino mice for morbidity and mortality for 3 days. The BRMT and CA tests were conducted with and without metabolic activation (S9). The study was approved by the institutional ethics committee (IEC) and institutional animal ethics committee (IAEC). ARE failed to show any mutagenic effects up to a dose of 5 mg/plate in BRMT. Also, ARE did not show any clastogenic activity in doses up to 2 mg/ml in CA test and in micronucleus test up to 2000 mg/kg body weight. These results were observed with and without metabolic activation (S9) under the stated experimental conditions. No mortality, morbidity, or any clinical signs were observed up to 3 days following ARE administration. Ashwagandha root extract failed to show any mortality in doses up to 2000 mg/kg oral dosage and did not show any mutagenic (genotoxic) effects in high concentrations.

Effect of Right Nostril Breathing on Cardiorespiratory Parameters and Reaction Time in Young, Healthy Humans: An Interventional Study.

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.

One-year outcomes after prostate artery embolization versus laser enucleation: A network meta-analysis.

Background: Although holmium laser enucleation (HoLEP) is considered a size-independent procedure for treatment of an enlarged prostate, prostate artery embolization (PAE) is emerging as an alternative modality to treat moderate and large benign prostatic hyperplasia. This study aims to compare the early post-operative and short-term efficacy of PAE and HoLEP. Methods: PubMed, Cochrane Library and EMBASE databases were searched. Network meta-analysis was performed following PRISMA-N-guidelines. Post-operative parameters analysed include international prostate symptom score (IPSS), quality of life (QOL), post-void residual urine (PVR), maximal uroflow rate (Qmax) and serious adverse events (SAE). Random effects model calculated weighted mean differences (WMD). If 95%CI crossed the line of no effect (WMD = 0), evidence indicated no statistically significant difference between treatments compared. Results: Qualitative and quantitative syntheses included 20 and 18 studies with 1991 and 1606 patients, respectively. At 3 months, there was no statistically significant difference between PAE and HoLEP in IPSS score improvement [WMD: -2.21: 95%CI: (-10.20, 5.78), favouring PAE], QoL score improvement [WMD: -0.22:95%CI: (-1.75, 1.32), favouring PAE] and PVR improvement [WMD: 26.97: 95%CI: (-59.53, 113.48), favouring HoLEP]. However, PAE was found inferior to HoLEP for Qmax improvement [WMD: 8.47, 95%CI: (2.89, 14.05), favouring HoLEP]. At 1-year follow-up, there was no statistically significant was found between PAE and HoLEP for IPSS score improvement [WMD:6.03, 95%CI: (-1.30, 13.35)], QoL score improvement [WMD: 0.03, 95%CI: (-1.19, 1.25)], PVR improvement [WMD:4.11, 95%CI: (-32.31, 40.53)] and Qmax improvement [WMD:2.60, 95%CI: (-2.20, 7.41)] with all differences favouring HoLEP. PAE was superior to HoLEP for SAE [PAE vs. HoLEP-OR: 0.68, 95%CI: (0.25, 1.37)]. Conclusion: HoLEP was superior to PAE at 3 months for Qmax improvement. There was no significant difference in IPSS, QoL, PVR and Qmax improvement at 1 year between PAE and HoLEP. PAE was also associated with lesser SAE compared to HoLEP. Studies on the long-term outcome of PAE are needed to establish the durability of early outcomes after PAE.

Sub-acute toxicity of Ashwagandha (Withania somnifera) root extract in wistar rats.

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. Material and methods: Sub-acute toxicity of Ashwagandha was done as per the OECD-407 guidelines and was carried out for 28 days where satellite group was observed for 43 days. Wistar rats, 30 male and 30 females, were included in the study with 10 [5 M, 5 F] animals per group. Laboratory procedures were performed in accordance with CPCSEA guidelines. Animals were housed in standard laboratory conditions and were administered drugs orally- vehicle to control group and Ashwagandha 200, 400, 800 mg/kg body weight/day to study group. General parameters were noted, blood collection was done for haematological and biochemical parameters. All the animals were sacrificed, dissected and observed for gross necropsy and organs of high dose groups from control and Ashwagandha groups were sent for Histopathological examination. Result: Gradual weight gain was observed in all the animals. No signs of intoxication and no changes in blood biochemistry were observed. Histopathological changes in organs were within normal limits. Conclusion: After repeated dose administration, Ashwagandha root powder extract did not show any major abnormality in a dose 5 times of the recommended human dose and above upto 800 mg/kg.

Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats.

Many pharmacological studies have been carried out to describe multiple biological properties of Ashwagandha (Withania somnifera) and the additional safety information on repeated dose toxicity is limited. Therefore, the aim of this study was to obtain safety data for KSM-66 Ashwagandha Root Extract (ARE) through repeated-dose toxicity in Wistar rats according to the Organisation for Economic Co-operation and Development (OECD) test guideline (TG 408). ARE was orally administered to rats at doses of 0, 500, 1000, and 2000 mg/kg body weight/day for 90-day and reversibility of effects of 0 and 2000 mg/kg body weight/day was assessed for 14 days. All the animals from treated, control, recovery control and recovery groups were observed for clinical signs of toxicity once daily, detailed clinical examination every week after dosing and before necropsy day. Mortality/Morbidity was observed twice daily. In addition, observations were noted in the detailed sensory reactivity, functional assessments, body weight, food consumption, ophthalmological examination, hematological parameters, biochemical parameters, organ weights, histopathological findings. The present results show that the no observed adverse effect level (NOAEL) of KSM-66 Ashwagandha Root Extract was considered to be 2000 mg/kg body weight/day in rats after repeated oral administration for 90-day under the present study conditions.

Evaluation of the Effect of Left Nostril Breathing on Cardiorespiratory Parameters and Reaction Time in Young Healthy Individuals.

BACKGROUND: Pranayama, a yogic breathing practice, produces several physiological responses in healthy individuals. Hypertension is a critical and booming public health challenge all over the world. Yoga is one of the effective methods to reduce blood pressure (BP) and pulse rate (PR). OBJECTIVE: To evaluate the effect of left nostril breathing (LNB) exercise on cardiorespiratory parameters and reaction time (RT) in young healthy individuals. MATERIALS AND METHODS: In this study, 106 young healthy individuals between 18 and 25 years of age were included. The 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) of volunteers were recorded at baseline (before exercise) and after two weeks of left nostril breathing exercise performed 45 minutes daily. RESULTS:  There was a significant reduction in SBP (126.64 ± 15.51 mmHg versus 116.29 ± 11.91 mmHg; Cohen's d (effect size): 0.87; p < 0.0001)), DBP (76.57 ± 14.87 mmHg versus 71.07 ± 11.39 mmHg; Cohen's d: 0.48; p < 0.0001), PR (85.32 ± 15.44/minute versus 81.77 ± 13.02/minute; Cohen's d: 0.27; p < 0.0001), and RR (14.26 ± 2.15/minute to 13.17 ± 2.03/minute; Cohen's d: 0.54; p < 0.0001). A significant increase was observed in VC (3.42 ± 0.62 versus 3.67 ± 0.65; Cohen's d: 0.39; p < 0.0001) and PEFR (467.81 ± 46.66 versus 498.29 ± 51.50; Cohen's d: 0.59; p < 0.0001). There was a significant decrement in auditory reaction time (ART) (164.36 ± 27.20 ms versus 143.84 ± 20.32 ms; Cohen's d: 0.85; p < 0.0001) and visual reaction time (VRT) (190.25 ± 31.48 ms versus 163.75 ± 21.72 ms; Cohen's d: 0.98; p < 0.0001). There was no significant change in maximum heart rate (MHR) after cardiorespiratory activity (CRA) (p > 0.434). CONCLUSION: Left nostril breathing is associated with a decrease in cardiovascular parameters and an increase in VC and PEFR. This technique may be useful for putting up a fight against the stress and strain of daily life. This simple exercise may also be a beneficial adjuvant to pharmacological therapy in hypertensive patients.

Adverse drug reactions reporting: Five years analysis from a teaching hospital.

Background: Adverse drug reactions (ADRs) are important cause of morbidity and mortality. Despite its known importance, rate and quality (completeness score) of ADR reporting is not satisfactory. The objective of this study was to analyze pattern and completeness score of ADRs during past five-years. Material and Methods: In this retrospective study, ADRs reported between 2017 to 2021 were analyzed according to year, gender, age-group, pharmacological class and department. The completeness score of ADRs was calculated. The number of sensitization programs conducted over 5 years and its impact on the completeness score was also evaluated. Results: A total of 104 ADRs were reported among 61 (58.6%) female and 43 (41.4%) male patients. Adults (18-65 years) comprised the most affected age group, accounting for 82 (79%) patients. Out of all, 35.5% ADRs were reported in 2018, whereas 27% were reported during 2021. Except during 2017, percentage of females with ADRs was more. Department of pulmonary medicine and dermatology contributed to maximum extent in ADR reporting. Antibiotics [23 (22.11%)], antitubercular drugs (AKT) [21 (20.19%)], and vaccines [13 (12.4%)] represented the most common agents with which ADRs were reported. ADR reporting was very low in 2017 (4/104). Percentage improvement in completeness score in 2021 vs. 2018 was 11.95% (P < 0.05). Positive trend in the improvement of average completeness score with number of sensitization programs was observed. Conclusion: Incidence of ADRs was more common in females. AKT and antimicrobials are commonly implicated in ADRs. Increase in awareness of ADR reporting through sensitization programs can help to improve rate and quality of reporting.

Postpartum Use of Shavari Bar® Improves Breast Milk Output: A Double-Blind, Prospective, Randomized, Controlled Clinical Study.

Background and objectives Appropriate nutrition, along with the establishment of lactation, is of paramount importance for the feeding mother and the growing neonate. Asparagus racemosus, a common name for Shatavari, is a well-known herb that has been used as a galactagogue in traditional Indian culture. It is also referenced in Ayurvedic medicine. Despite multiple formulations available, palatability has been a concern always as Shatavari is very bitter. We have devised a palatable and nutritionally rich formulation of Shatavari with no artificial ingredients. To understand the efficacy, we have conducted this double-blind, prospective, randomized, controlled study to evaluate the effect of oral Shatavari formulation (Shavari Bar®) on breast milk output in postpartum women. Methods A prospective, randomized, parallel-group, double-blind, placebo-controlled study was conducted at two centers in women with gestational age 37 weeks or more who intended to breastfeed. Hundred and four women were screened, of which 78 were randomized to receive either bar containing Shatavari and oats (n=39, study) or an identical placebo bar (n=39, control). All 78 women completed the study, 61 delivered by a lower segment Caesarean section (LSCS), and 17 had a full-term normal vaginal delivery. Time to first noticeable breast fullness was measured and expressed milk volume measurements were done 72 hours after delivery or after consumption of four bars, whichever was later using a standardized breast pump. Comparison between the two groups was analyzed using a t-test. Results Demography and baseline data of patients enrolled were similar in the two groups. The mean total milk volume expressed was higher (p=0.008) with Shavari (64.74 ml) compared to placebo (49.69 ml). The time to breast fullness was shorter (p=0.024) with Shavari (30.49 hours) compared to placebo (38.09 hours). No adverse events were noted in either of the study groups. Global assessment of the satisfaction of mothers with lactation, the well-being of the child, taste, and ease of use was better in the treatment arm than in the placebo arm. Conclusion The use of the Shavari bar can be an effective option in postpartum women to establish early lactation and build confidence in breastfeeding along with nonpharmacological intervention.

Comparative evaluation of postoperative pain following chemomechanical preparation of single-rooted nonvital teeth with symptomatic apical periodontitis with and without laser irradiation: A double-blind randomized placebo controlled clinical trial.

Background: Postoperative pain can occur because of residual infection even after effective chemomechanical preparation. This study aimed to compare postoperative pain after chemomechanical preparation with placebo and laser irradiation in nonvital teeth having symptomatic apical periodontitis. Materials and Methods: Sixty (n = 30) participants after obtaining written consent were enrolled in the study. In Group 1, chemomechanical preparation followed by mock laser therapy was carried out in which laser tip was applied but not activated. In Group 2, chemomechanical preparation followed by a laser irradiation was applied and activated. Postoperative pain scores were evaluated at baseline, 24 h, 48 h, and 72 h using the Visual Analog Scale. Preoperative and postoperative percussion pain scores were also recorded. Subjects needing rescue medication were recorded as well. Mann-Whitney U test and Wilcoxon test were used for intergroup comparison and intragroup comparison. The Chi-square test was used for comparing rescue medication. Results: There was significant reduction in pain scores in the laser group as compared to placebo group at all time points. There was also significant difference in the preoperative and postoperative percussion pain scores. 9 and 3 subjects required rescue medication in Groups 1 and 2, respectively. Conclusion: Laser irradiation following chemomechanical preparation led to significant reduction in postoperative pain and can be considered as a valuable adjunct.

Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.

ETHNOPHARMACOLOGICAL RELEVANCE: Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia. MATERIAL AND METHODS: We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed. RESULTS: In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group. CONCLUSION: The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.

Efficacy of Cilnidipine (L/N-type Calcium Channel Blocker) in Treatment of Hypertension: A Meta-Analysis of Randomized and Non-randomized Controlled Trials.

INTRODUCTION:  Hypertension is one of the most common cardiovascular diseases, and the prevalence of hypertension continues to rise across the globe. National and international guidelines recommend angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), diuretics, and beta-blockers for the management of hypertension. CCBs are among the most used antihypertensive medications and Cilnidipine is a newer dihydropyridine CCB shown to have a prolonged antihypertensive property. OBJECTIVE:  This meta-analysis of comparative randomized and non-randomized clinical trials evaluated the effect of Cilnidipine monotherapy or combination therapy on systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate (PR) over 48 weeks of therapy. STUDY DESIGN:  PubMed (MEDLINE) and Google scholar databases were searched to identify studies designed to evaluate the effects of Cilnidipine in the treatment of hypertensive patients. The study criteria for inclusion into the meta-analysis were all prospective, randomized, and non-randomized clinical studies published till March 2021, studies published in a peer-reviewed journal, the inclusion of patients with hypertension, assessment of blood pressure and heart rate, and a follow-up of four weeks or longer. The initial search identified 82 potential articles; of these, 24 met the inclusion criteria. Studies with <4 weeks treatment period and those not having a CCB were excluded. OUTCOMES:  Change in SBP, DBP, and PR from baseline at the end of therapy compared between the Cilnidipine and other CCB's. RESULTS: Cilnidipine caused a significant reduction (p<0.05) in SBP, DBP, and PR at end of therapy, whereas the reduction in SBP, DBP, and PR with Cilnidipine was similar to other CCB's (p>0.05). The results of this meta-analysis revealed that there were no significant differences in the efficacy in the treatment of hypertensive patients with Cilnidipine and the other therapies. CONCLUSION:  Cilnidipine has similar anti-hypertensive effects compared with other first-line antihypertensive drugs commonly used in practice. We recommend Cilnidipine as a novel first-line CCB for the management of hypertension either as a monotherapy or as a combination therapy.

Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study.

BACKGROUND: The aim of the study is to assess the anxiolytic effects of yogic relaxation technique (YRT) in patients requiring root canal treatment (RCT). MATERIALS AND METHODS: In this prospective, randomized, placebo-controlled study, 30 patients undergoing RCT with baseline visual analog scale for anxiety (VAS-A) of score >4 were divided into Group 1: YRTs; Group 2: alprazolam (0.25 mg/0.5 mg), and Group 3: placebo. After 30 min of completion of YRT, endodontic treatment was performed. Reduction in anxiety was analyzed using state anxiety score (domain) of the state-trait anxiety inventory scale. RESULTS: There was no significant difference in anxiety score 1 h before RCT between groups (P = 0.401). Ten minutes before (P < 0.0001) and after RCT (P < 0.0001), there was significant difference between groups (yogic relaxation vs. alprazolam [P < 0.0001]; yogic relaxation vs. placebo [P < 0.0001]). Ten minutes before RCT, yoga relaxation showed significant difference in anxiety score for pain versus alprazolam and placebo (P < 0.0001 for both). Ten minutes after RCT, the change from baseline in mean anxiety score for pain was significantly different with yogic relaxation (versus alprazolam [P = 0.043]; versus placebo [P = 0.002]). As per the global assessment of efficacy, the response was excellent in 9 (90%), 2 (20%), and 1 (10%) patients in yoga relaxation group, alprazolam group, and placebo group, respectively. Difference in response between three groups was significant (P < 0.0001). There was no significant difference in the global assessment of tolerability between three groups (P = 0.535). No adverse events were reported. CONCLUSION: Before RCT, YRT is an effective alternative to anxiolytic agents, alprazolam.

COVID-19 and Management of Severe Acute Respiratory Infection (SARI): A Questionnaire-Based Study Among Indian Healthcare Professionals.

BACKGROUND: COVID-19 presenting as SARI (severe acute respiratory syndrome) mandates the need for ICU (intensive care unit) hospitalization, increasing healthcare burden. This study aims to determine knowledge of healthcare professionals towards management of SARI in COVID-19 suspected cases. METHODS: A total of 313 healthcare professionals from the state of Maharashtra, India completed a questionnaire-based survey study adapted from the WHO interim guidance for management of SARI in COVID-19 suspected cases. Convenience sampling method was used and the distribution of responses was presented as frequencies and percentages. Sub-groups were classified on the basis of gender, age, profession and ICU vs. Non-ICU setting. Descriptive statistics were performed for all groups based on percentage of correct responses and individual pairwise comparisons were done using the Chi-Square test. RESULTS: The median and mean percentage of correct responses for all sub groups was only 66.80% and 58.62% respectively. A higher percentage of total correct responses were those from the ICU setting with a higher overall performance from medical postgraduates. The nursing and allied healthcare professionals had a poor overall performance. CONCLUSIONS: The findings indicate lacunae in several aspects of SARI management which calls for nationwide studies and implementation of comprehensive training programmes. A uniform structured training program with team-oriented crisis resource management suitable for all healthcare professionals irrespective of prior training in COVID-19 management must be implemented. Furthermore, the findings of this study can serve as a baseline to develop training resources for healthcare professionals for COVID-19 management.

COVID-19 Awareness Among Healthcare Students and Professionals in Mumbai Metropolitan Region: A Questionnaire-Based Survey.

Background and objectives The rapid and extensive spread of the COVID-19 pandemic has become a major cause of concern for the healthcare profession. The aim of this study is to assess the awareness of COVID-19 disease and related infection control practices among healthcare professionals and students in the Mumbai Metropolitan Region. Materials and methods A total of 1562 responders from the Mumbai Metropolitan Region completed a questionnaire-based survey on the awareness, knowledge, and infection control practices related to COVID-19 infection in the healthcare setting. The questionnaire was adapted from the current interim guidance and information for healthcare workers published by the US Centers for Disease Control and Prevention (CDC). Convenient sampling method was used for data collection and the distribution of responses was presented as frequencies and percentages. Descriptive statistics were performed for all groups and subgroups based on the percentage of correct responses. Individual pairwise comparisons were done using the median test for the percentage of correct responses. Results The overall awareness for all subgroups was adequate with 71.2% reporting correct answers. The highest percentage of correct responses were from undergraduate medical students and the lowest was from non-clinical/administrative staff. Less than half of the total respondents could correctly define "close contact." More than three-fourths of the responders were aware of the various infection control measures like rapid triage, respiratory hygiene, and cough etiquette and having a separate, well ventilated waiting area for suspected COVID-19 patients. However, only 45.4% of the responders were aware of the correct sequence for the application of a mask/respirator, and only 52.5% of the responders were aware of the preferred hand hygiene method for visibly soiled hands. Conclusion There is a need for regular educational interventions and training programs on infection control practices for COVID-19 across all healthcare professions. Occupational health and safety are of paramount importance to minimize the risk of transmission to healthcare students and professionals and provide optimal care for patients.

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Insomnia and Anxiety: A Double-blind, Randomized, Placebo-controlled Study.

Introduction Insomnia is a prevalent sleep disorder that can profoundly impact a person's physical health and mental wellbeing. Most of the currently available drugs for insomnia exert adverse effects. Hence, alternative herbal therapies could be effective in treating insomnia. Ashwagandha, a proven "Rasayana" from ancient Ayurveda is having the required potential to treat insomnia. Objective To determine the efficacy and safety of Ashwagandha root extract in patients with insomnia and anxiety. Methods This was a randomized, double-blind, placebo-controlled study conducted at Prakruti Hospital, Kalwa, Maharashtra, India. A total of 60 patients were randomly divided into two groups: test (n = 40) and placebo (n = 20) in a randomization ratio of 2:1. Test product was a capsule containing highest concentration full-spectrum Ashwagandha root extract 300 mg, and the placebo was an identical capsule containing starch. Both treatments were given twice daily with milk or water for 10 weeks. Sleep actigraphy (Respironics Philips) was used for assessment of sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE) and wake after sleep onset (WASO). Other assessments were total time in bed (sleep log), mental alertness on rising, sleep quality, Pittsburgh Sleep Quality Index (PSQI), and Hamilton Anxiety Rating Scale (HAM-A) scales. Results Two patients, one from each group, did not complete study and the per-protocol dataset (n = 58) included 29 and 19 patients from test and placebo, respectively. The baseline parameters were similar in the two groups at baseline. The sleep onset latency was improved in both test and placebo at five and 10 weeks. However, the SOL was significantly shorter (p, 0.019) after 10 weeks with test [29.00 (7.14)] compared to placebo [33.94 (7.65)]. Also, significant improvement in SE scores was observed with Ashwagandha which was 75.63 (2.70) for test at the baseline and increased to 83.48 (2.83) after 10 weeks, whereas for placebo the SE scores changed from 75.14 (3.73) at baseline to 79.68 (3.59) after 10 weeks. Similarly, significant improvement in sleep quality was observed with test compared to placebo (p, 0.002). Significant improvement was observed in all other sleep parameters, i.e., SOL, SE, PSQI and anxiety (HAM-A scores) with Ashwagandha root extract treatment for 10 weeks. Conclusion Ashwagandha root extract is a natural compound with sleep-inducing potential, well tolerated and improves sleep quality and sleep onset latency in patients with insomnia at a dose of 300 mg extract twice daily. It could be of potential use to improve sleep parameters in patients with insomnia and anxiety, but need further large-scale studies.

Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study.

Background Stress, anxiety and impeded sleep are a frequent feature of life in modern societies. Across socio-economic strata, stress, anxiety and ineffective sleep detract from healthful living and serve as precursors of various ailments. The use of herbs to offset these antecedents and outcomes has greatly increased in recent years. Ashwagandha, an adaptogenic Ayurvedic herb, has been often used to combat and reduce stress and thereby enhance general wellbeing. While there have been other studies documenting the use of Ashwagandha for stress resistance, this is the first study to use a high-concentration root extract while also varying the dosage substantially. Therefore, this is the first study to offer insight into dose-response of a high concentration root extract. Material and methods In this eight-week, prospective, randomized, double-blind, placebo-controlled study, the stress-relieving effect of Ashwagandha root extract was investigated in stressed healthy adults. Sixty male and female participants with a baseline perceived stress scale (PSS) score >20 were randomized to receive capsules of Ashwagandha extract 125 mg, Ashwagandha extract 300 mg or identical placebo twice daily for eight weeks in a 1:1:1 ratio. Stress was assessed using PSS at baseline, four weeks and eight weeks. Anxiety was assessed using the Hamilton-Anxiety (HAM-A) scale and serum cortisol was measured at baseline and at eight weeks. Sleep quality was assessed using a seven-point sleep scale. A repeat measures ANOVA (general linear model) was used for assessment of treatment effect at different time periods. Post-hoc Dunnett's test was used for comparison of two treatments with placebo. Results Two participants (one each in 250 mg/day Ashwagandha and placebo) were lost to follow-up and 58 participants completed the study. A significant reduction in PSS scores was observed with Ashwagandha 250 mg/day (P < 0.05) and 600 mg/day (P < 0.001). Serum cortisol levels reduced with both Ashwagandha 250 mg/day (P < 0.05) and Ashwagandha 600 mg/day (P < 0.0001). Compared to the placebo group participants, the participants receiving Ashwagandha had significant improvement in sleep quality. Conclusion Ashwagandha root aqueous extract was beneficial in reducing stress and anxiety.

Public Awareness of the Emergency Medical Services in Maharashtra, India: A Questionnaire-based Survey.

Background and objectives The most widely used emergency medical services (EMS) model in India is the '108' emergency service which primarily functions as an emergency response system to attend patients in need of critical care, trauma and accident victims. This is an observational cross-sectional study which was conducted using a questionnaire that asks the participants about their awareness and opinion of the current EMS system. The results of this study will enable us to ascertain the level of awareness of EMS among the population and address any misconceptions if they exist. Materials and methods All participants had to complete a 24-item self-administered questionnaire consisting of eight socio-demographic questions and 16 questions based on the EMS system. Questions regarding the development of the '112' unified emergency service were also included. The convenient sampling method was used for data collection. The distribution of responses was examined using frequencies and percentages. Further analysis was done using the Chi-square test to compare responses between various subgroups based on the age, gender, profession, and level of education. Results A total of 1220 people from the state of Maharashtra responded to the survey and the maximum responses were from Mumbai. Majority of the respondents (59.2%) were from the age group of 15 to 30 years and, most of our responders had received education at the graduate level or above (78.2%). Only 17.5% of the respondents said that they will try to check for responsiveness if they saw a person lying unconscious by the side of the road with the scene being free of any danger. Interestingly, 78.9% of the healthcare professionals who participated in this survey would not check for responsiveness. Only 76.2% of the respondents knew that '108' is the number to dial in case of a medical emergency and about a quarter of them was not aware of it. It may seem that a good number of people are aware of the number. However, with the high number of fatalities occurring every day due to lack of medical facilities and a high current annual death toll on the roads, 100% of the population should know the emergency number. Only 20.2% of the respondents had called the EMS and asked for an ambulance. 68.5% of the respondents would immediately move out of the way and 27.5% of them would move out of their way if the ambulance's lights and sirens were on. About two-thirds of the respondents were unaware of the development of a unified emergency number (112). However, a large majority (82.9%) were in favor of having a unified emergency number instead of a different number for each emergency. Only 43.8% of the respondents were of the opinion that the current EMS coverage was inadequate. 24.9% of the participants rated the current EMS as good, whereas 53.5% rated the EMS average and 16.9% rated it poor. Conclusions An effort should be made to make 100% of the population aware of this service. The first step for increasing awareness would be starting various advertisement campaigns. The next step would be to implement the unified emergency number (112) to address all kinds of distress calls such as police, fire, and ambulance. A very small proportion of the population is trained in first-aid or basic trauma life support. Awareness campaigns and training sessions for the general public should be conducted for the same. It is also necessary to spread awareness and help the populace know about the Good Samaritan law.

A Randomized, Clinical Trial to Evaluate Efficacy and Tolerability of Trypsin:Chymotrypsin as Compared to Serratiopeptidase and Trypsin:Bromelain:Rutoside in Wound Management.

INTRODUCTION: Systemic enzyme therapy can play an important role in maintaining normal inflammatory processes within the body and thereby helps support and speed up healing. In the course of the anti-inflammatory action, enzymes degrade damaged cells and necrotic material and, through the inactivation of mediators and toxic products, they restrict the edema and pain. METHOD: The study conducted at Grant Medical College, Mumbai, India was a clinical trial comparing the efficacy and tolerability of three oral enzyme treatment groups-oral tablets containing trypsin:chymotrypsin (TC) (Chymoral Forte®), serratiopeptidase (S) 5 mg oral tablets, and oral enzyme tablets containing trypsin 48 mg, bromelain 90 mg, and rutoside 100 mg (TBR)-to evaluate their healing potential in surgical wounds after orthopedic surgery. RESULTS: A total of 75 patients were screened, randomized, and divided into three groups in 1:1:1 ratio receiving either of the three treatments. In the TC group, erythema was significantly reduced from 3.44 on day 3 to 1.16 on day 10 (p < 0.01). There was significantly better reduction in erythema scores in the TC group as compared to S and TBR groups (p < 0.05) at each follow-up visit. Similarly reduction in the local irritation, wound discharge, edema, induration, and tenderness score with TC treatment at the end of the study was significantly higher than that observed in the other two groups. In addition TC showed significant reduction in pain on the VAS scale (p < 0.01). Global assessment of response to therapy for efficacy and tolerability was reported to be good to excellent in 88% and 92% of the patients on TC as compared to 12% and 8% with S and 12% and 8% with TBR. CONCLUSION: TC provides a better resolution of symptoms of inflammation after orthopedic surgery as compared to S and TBR, thus facilitating better wound healing. Further studies are warranted to confirm the findings. TRIAL REGISTRATION: Clinical Trial Registry of India (Reg. No. CTRI/2011/07/001920).

Comparative evaluation of remineralizing potential of Fluoride using three different remineralizing protocols: An in vitro study.

BACKGROUND: Remineralization of noncavitated enamel is dependent on the bioavailability of calcium, phosphate, and hydroxyl ions in saliva. However, it is enhanced by the presence of fluoride. This study compared the remineralizing potential of three different topical fluoride agents. MATERIALS AND METHODS: Fifteen extracted premolars were selected for the study. The crown of each tooth was longitudinally sectioned buccolingually and mesiodistally using a diamond disc so as to obtain sixty specimens which were embedded in acrylic molds. The specimens were immersed in demineralizing solution for 3 days. The specimens were randomly assigned to four groups, namely Duraphat fluoride varnish, ReminPro paste, ClinPro Tooth Crème, and control group (no surface treatment). A pH cycling includes alternate demineralization and remineralization. Surface mean hardness (SMH) was recorded with 50 g load for 5 s using VHN machine at baseline, after demineralization and pH cycling. The four groups were compared for difference in SMH using one-way ANOVA followed by Tukey-Kramer test. All testing was done with alpha 0.05. RESULTS: SMH recovery results for ClinPro, Duraphat, and ReminPro were 54.88%, 43.42%, and 26.86%, respectively. The difference in the percentage SMH recovery for ClinPro paste was better than Duraphat and ReminPro, and this difference was statistically significant (P < 0.05). CONCLUSIONS: ClinPro tooth Crème showed the best remineralization potential among the three materials tested followed by Duraphat and ReminPro.