Screen Use Time and Its Association With Mental Health Issues in Young Adults in India: Protocol for a Cross-Sectional Study.

BACKGROUND: Screen use time has increased in the past decade owing to the increased availability and accessibility of digital devices and the internet. Several studies have shown an association between increased screen use time and mental health issues such as anxiety and depression. However, studies in the young adult population-a demographic with high screen use-and in low- and middle-income country settings are limited. OBJECTIVE: This protocol describes a study that aims to measure self-reported screen use times and patterns in young adults (18-24 y) in India and assess if increased screen use time is associated with poorer mental well-being. METHODS: This protocol describes a cross-sectional study of a pan-India, web-based convenience sample of young adults (18-24 y) with access to digital devices with a screen and a minimum of secondary school education. Participants will be recruited through people in the professional networks of the investigators, which includes pediatricians. The survey will also be distributed via the social media pages of our organization (X [X Corp], Instagram [Meta], Facebook [Meta], etc). Sociodemographic details will be collected through a questionnaire designed by the authors; screen use time and patterns will be assessed using an adaptation of the Screen Time Questionnaire to include data on different apps and websites used on digital devices; and mental health parameters will be gauged using the Warwick-Edinburgh Mental Well-Being Scale, Generalized Anxiety Disorder Scale, Perceived Stress Scale, and Patient Health Questionnaire. For statistical analysis, we will consider the following variables: (1) the primary independent variable is screen use time; (2) other independent variables include age, gender, residence: rural or urban, educational qualifications, employment status, stress associated with familial financial status, average sleep time, number of people living in a house or rooms in that house, BMI, substance use, and past psychiatric history; and (3) dependent variables include mental well-being, depression, anxiety, and perceived stress. To quantify the association between screen use time and mental health, we will perform a Bayesian multivariate multiple regression analysis that models the possibility of multiple alternative hypotheses while accounting for relevant sociodemographic covariables. RESULTS: The survey instrument has been designed, and feedback has been obtained from the domain experts and members of our organization whose profile is similar to the potential study participants. The final data received after this study has been conducted will be analyzed and shared. As of January 2023, we have not yet initiated the data collection. CONCLUSIONS: Based on the findings of this study, we will be able to establish a correlation between device- and use-specific screen use time and various mental health parameters. This will provide a direction to develop screen use time and mental health guidelines among young adults. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39707.

Safety and Efficacy of the Ayurvedic Formulation Guduchi Ghana Vati as a Preventive Remedy in COVID-19.

Background and objectives Guduchi (Tinospora cordifolia) is a well-known Ayurvedic herb used as a preventive and curative remedy for various infections and immunity-related conditions. This study aimed to evaluate Guduchi Ghana Vati as a preventive remedy for COVID-19 and non-COVID-19 infections in a healthy population. Materials and methods An open-labeled, multi-centric, randomized, comparative, interventional, prospective community-based clinical study was conducted on healthy individuals at the community level in five different districts of Rajasthan by the National Institute of Ayurveda (NIA), Jaipur, India. Participants were divided into two groups. One group received Guduchi Ghana Vati as an intervention for 45 days, and the control group did not receive any intervention. Incidences of COVID-19 infection, non-COVID-19 infections, their severity, and hospitalization requirements were assessed. Safety was evaluated through monitoring of adverse reactions. Results Among the 10,022 participants who completed the study, the incidence of COVID-19 infection was found to be lower in those taking Guduchi Ghana Vati compared to the control group; however, the difference was statistically non-significant. The severity of COVID-19 based on the WHO ordinal scale was found to be significantly lower in the Guduchi Ghana Vati group compared to the control group. The number of episodes and severity of non-COVID-19 illness were also significantly lower in participants taking Guduchi Ghana Vati compared to the control group. No major adverse drug reactions were observed. Conclusion Guduchi Ghana Vati has the potential to act as a safe and effective remedy for the prevention of infection and immunity-related conditions, including COVID-19.

A Pilot, Open-Label, Proof-of-Concept Study To Evaluate the Efficacy and Safety of Asthiposhak® Tablets in Participants Suffering From Asthikshaya or Osteopenia.

Introduction Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to debilitating bone fractures. This study aimed to assess the efficacy of Asthiposhak® Tablets in individuals with Asthikshaya (osteopenia) by measuring changes in the bone mineral density (BMD) score before and after the intervention, specifically between visit 1 (baseline) and visit 8 (after 180 days of treatment). Methods The single-arm study involved the screening of participants for Asthikshaya (osteopenia) using baseline investigations, which included a bone mineral density (BMD) assessment through a dual-energy X-ray absorptiometry (DEXA) scan. A total of 36 participants were enrolled in the study, who took two Asthiposhak Tablets three times a day with lukewarm water, for a period of 180 days. Safety assessments, along with evaluations of BMD (DEXA Scan), Ayurvedic Symptom Score, and serum biochemical markers, were conducted through blood investigations. Efficacy and safety data were analyzed using 'intention-to-treat' analysis. Descriptive statistics were used to express data in percentages, mean ± SD, or median (IQR). Data at different intervals were compared using paired t-tests or Wilcoxon signed-rank tests. One-way analysis of variance (ANOVA) with Bonferroni correction tested the significance between visits for the Ayurvedic Symptom Score, and Friedman's two-way analysis of variance by ranks measured differences in vital parameters. The significance level used was p<0.05. Results Out of the initially recruited 36 participants, 30 successfully completed the study, consisting of 12 males and 18 females, with an age range of 40 to 70 years and a mean age of 51.33 years. After 180 days of treatment with Asthiposhak Tablets, a statistically significant (p<0.05) improvement in hip and spine BMD (T-score) was observed. Additionally, significant reductions in the mean Total Ayurvedic Symptom Score were noted at both 90 and 180 days of treatment compared to day 0. Moreover, the levels of bone-specific alkaline phosphatase and osteocalcin, serum bone markers, showed statistically significant (p<0.05) reduction after 180 days of treatment compared to day 0. Importantly, all safety variables, including laboratory investigations, remained within the normal range following the 180-day treatment with Asthiposhak Tablets. Conclusion Asthiposhak Tablets exhibited significant efficacy in enhancing both BMD (T-score) and Ayurvedic Symptom Score, thereby substantiating their osteoprotective potential in individuals with Asthikshaya (osteopenia). Furthermore, the tablets were found to reduce the levels of biochemical markers, such as serum bone-specific alkaline phosphatase and osteocalcin, suggesting their anti-resorptive action.