Effect of Yoga on Immunity in Healthcare Professionals during the COVID-19 Pandemic – A Pilot Study

Abstract

Background:

The COVID-19 pandemic posed significant mental and physical challenges for healthcare professionals (HCPs), leading to increased stress and potential immune dysregulation. Yoga practice, has been suggested to enhance immunity and alleviate stress. This pilot study aimed to assess the impact of yoga intervention on immune markers, stress levels, and quality of life among HCPs actively working during the pandemic.

Methodology:

A single-center, open label randomized controlled pilot study was conducted at tertiary care centre, with 36 participants. Physicians were randomly assigned to either a yoga intervention group (n=18) or a control group (n=18). The intervention included guided online yoga sessions for 12 weeks. Immunological markers (IL-6, IL-12, CRP, INF-gamma, TNF-alpha) were measured using ELISA at baseline and post-intervention. Stress levels and quality of life were assessed using the WHO-BREF questionnaire. Statistical analysis was performed Microsoft excel M365 software, employing t-tests.

Results:

Significant improvements were observed in immune markers, particularly a reduction in IL-12 (p=0.0165) and CRP (p=0.001), alongside a marked increase in INF-gamma (p=0.001) in the yoga group. BMI significantly improved (p=0.0194), though stress levels and most quality-of-life domains remained unchanged, except for social relationships (p=0.0279). Correlation analysis suggested a strong relationship between BMI reduction and immune modulation.

Conclusion:

Yoga intervention demonstrated potential benefits in modulating immunological markers and improving BMI among physicians. While stress reduction was not significant, enhanced social relationships and immune function suggest yoga as a complementary approach for HCPs well-being during high-stress periods. Further large-scale studies are recommended to validate these findings.

Introduction

The COVID-19 pandemic emerged as a global crisis, contributing to economic instability and widespread psychological distress. Healthcare professionals (HCPs), being at the frontline, are particularly vulnerable to elevated stress levels due to prolonged exposure to risks, long working hours, and resource limitations. Compounding the issue is an “infodemic” of misinformation, which has intensified anxiety, depression, and psychological burnout. Many regions lack the infrastructure to support healthcare providers and those in need, whereas the absence of definitive treatments adds to the misperception.[1] Strengthening immunity and preventing cytokine release syndrome are crucial for mitigation. Primary preventive measures include vaccination, masking, and holistic practices like yoga.[2] HCPs closely interacting with COVID-19-infected patients and their lifestyle restrictions face substantial stress burdens during the COVID-19 pandemic.[2,3] This psycho-physical distress, known as burnout, not only compromises the well-being of HCPs but also negatively impacts functioning.[4] Studies indicate that mental health assessments revealed a significant proportion of healthcare workers experienced high rates of anxiety (24.7%), depression (19.2%), and stress (13.9%), with key contributors including psychological distress and physical health challenges.[5,6,7,8,9]

Yoga, an ancient Indian practice rooted in a psychosomatic approach, aims to harmonize the mind and body by regulating emotions, thereby strengthening physical, mental, emotional, and spiritual well-being.[10] It also boosts innate immunity and supports mental health.[11] Yoga has been practiced globally for centuries and described in various literature.[12,13,14] Research highlights that guided asanas, pranayama, and meditation enhance immune responses. Recent studies emphasize the mind–body connection to promote holistic health.[10] Although targeted yoga interventions have already been utilized for COVID-19 recovery in India and the UK, more research is necessary to establish their effectiveness.[11]

In this challenging work environment, yoga interventions may offer an effective approach to help HCPs maintain stable psychophysical well-being. While existing literature suggests yoga interventions demonstrate potential efficacy in mitigating occupational stress among healthcare personnel, there remains a critical need for methodologically rigorous trials with robust study designs to establish conclusive empirical evidence and validate these preliminary findings.[4] This study aims to assess the potential advantages of a 12-week yoga program on their holistic wellness. The primary objective is to measure the alterations in immunity markers among physicians following a 12-week yoga regimen. The secondary objective involves evaluating how yoga influences stress levels and quality of life, and comparing these changes between those undergoing the intervention and those in the control group. Anticipated results encompass measuring shifts in immunity markers, stress levels, and quality of life scores in participating physicians.

Methodology

This study involves screening participants, collecting baseline immunity markers (interleukin-6 [IL-6], IL-12, C-reactive protein [CRP], interferon-gamma [INF-γ], tumor necrosis factor-alpha [TNF-α]), and PSS and WHOQOL-BREF scores, followed by randomization into yoga and control groups. After 12 weeks, both groups will be reassessed for immunity markers and psychological well-being measures, as shown in Figure 1.

Figure 1.

Flowchart of study plan

Study design

Open-label randomized controlled trial-Single Centre Pilot Study.

Inclusion and exclusion criteria

The inclusion criteria for this study comprise doctors actively working during the COVID-19 pandemic at AIIMS, Rishikesh. Exclusion criteria encompass individuals who are unwilling to participate, those with autoimmune disorders or immunodeficiency, individuals engaging in yoga or any form of exercise for the past 3 months, those who have tested positive for COVID-19, and individuals with any structural deformities or physical conditions that render them unfit to perform yoga asanas.

Sample recruitment

This pilot study was conducted at the All India Institute of Medical Sciences, Rishikesh, involving the recruitment of doctors. A total of 60 subjects were approached to participate in the study. A total of 42 subjects agreed to participate, and only 36 participants completed the study. The participants were randomly allocated to Group I (Control) or Group II (Yoga Intervention) [Figure 2] through a computer-generated randomization process. Group II receives a 12-week yoga intervention, whereas Group I serves as the control group.

Figure 2.

Flowchart of the study methodology for sample recruitment and follow-up

Yoga intervention

A trained yoga instructor was assigned to train participants through guided yoga practices through online video (Google Meet), which include a combination of loosening practices, yoga asanas, kriya, pranayama, and dhyana (meditation). The specific asanas listed are: Tāḍāsana, Pada-hastāsana, ArdhaChakrāsana, Trikonāsana, Vīrabhadrāsana, Bhadrāsana, ArdhaUṣhṭrāsana, Sasakāsana, Marjariāsana, UtthanaMaṇdukāsana, Vakrāsana, Makarāsana, Bhujangāsana, Shalabhāsana, Setubandhāsana, Utthanapādāsana, ArdhaHalāsana, Markatāsana, PawanaMuktāsana, Shavāsana.

Sample collection

The study was approved by the Institute Ethics Committee (IEC) and registered with the Clinical Trial Registry, and after taking informed consent, the sociodemographic details of the participants were collected. Baseline blood samples were taken to assess the levels of immunity markers such as IL-6, IL-12, CRP, IFN-γ, and TNF-α. In addition, the baseline perceived stress score and quality of life are evaluated using the WHO-BREF questionnaire.[15]

Upon completion of the 12 weeks, blood samples were again collected from both groups to measure the levels of the aforementioned immunity markers. Furthermore, the participants were administered the WHOQOL-BREF questionnaire to reassess changes in their perceived stress levels and quality of life.

Cytokine levels (enzyme-linked immunosorbent assay)

IL-6, IL-12, CRP, IFN-γ, and TNF-α levels were measured using sandwich enzyme-linked immunosorbent assay kits from Diaclon. CRP was measured by enzyme immunoassay using a kit from Diagnostics Biochem Canada.

Statistical analysis

Statistical analysis was performed using the paired Student’s-t-test to compare mean values between pretest and posttest measurements within each group, and an unpaired t-test was used for the independent group. A significance level (α) of ≤0.05 was chosen, indicating a 5% or less chance of observing the obtained results due to random variation or sampling error. P ≤ 0.05 was deemed statistically significant, leading to the rejection of the null hypothesis in favor of the alternative hypothesis. The interpretation of results focused on both statistical significance and the practical relevance of observed differences. Overall, these methods facilitated a robust analysis, ensuring reliable conclusions based on the data collected. The latest version of Microsoft Excel, which is part of Microsoft 365, was used for data analysis.

Results

Demographic data

Eighteen participants were recruited for each group and followed up for 12 weeks. Both groups were similar in mean age, 29 ± 1.02 in the Control Group (C) and 28.10 ± 0.77 in the Yoga Group (Y). The comparison of age between the yoga intervention (Y) and control groups (C) suggests [Figure 3a] that they are fairly similar in terms of the age distribution, as evidenced by the nonsignificant (P = 0.49). Gender distribution appears to be a significant difference between the two groups (P = 0.045), in the yoga intervention group (Y1) (M/F: 6/12) compared to the control group (C1) (M/F: 12/6).

Figure 3.

Pre and post assessment of Physiological Markers such as (a) Age; (b) Body mass index; (c) Waist circumference; (d) Perceived Stress Scale (PSS). C1: Control on Day 1, C90: Control on Day 90, Y1: Yoga on Day 1, Y90: Yoga “intervention” Day 90

Physiological markers

The present study evaluated the impact of a 12-week yoga intervention on various physiological and psychological parameters among HCPs during the COVID-19 pandemic. A significant improvement in body mass index (BMI) was observed in the Yoga group, where participants showed [Figure 3b] a reduction from 22.3 ± 2.27 to 21.29 ± 1.89 (P = 0.0151), indicating the potential role of yoga in supporting healthy weight management. In contrast, the control group experienced a slight but statistically significant increase in BMI (P = 0.0232), possibly due to reduced physical activity or heightened stress levels during the same period. Waist circumference [Figure 3c] showed a nonsignificant decrease in the Yoga group and a nonsignificant increase in the control group, suggesting that although the yoga intervention may trend toward reducing central adiposity, the effect may require a longer duration or larger sample size to reach statistical significance.

Assessment of quality of life and stress

In terms of psychological health, the perceived stress scale (PSS) scores showed [Figure 3d] a slight reduction in the Yoga group and a minor increase in the control group, although neither change was statistically significant. This trend supports existing literature indicating yoga’s potential to reduce stress, but the current findings highlight the need for more extensive studies to confirm its effectiveness in high-stress populations like healthcare workers. Evaluation of quality of life through the WHOQOL-BREF resulted in significant improvement in physical health (WHOQOL-BREF Domain 1) among participants in the Yoga group, with scores increasing from 68.71 ± 7.94 to 75.33 ± 7.92 (P = 0.0000), indicating a strong positive impact of the 12-week yoga intervention on perceived physical well-being shown in Figure 4. The control group showed a nonsignificant decline in this domain. Other domains – psychological well-being, social relationships, and environmental factors did not show statistically significant changes in either group illustrated in Table 1. These findings suggest that while the yoga intervention notably enhanced physical health, its influence on other aspects of quality of life may require a longer duration, greater intensity, or integration with additional mental health support strategies to produce significant benefits.

Figure 4.

Pre and post assessment of WHOQOL-BREF Scores in domains such as (a) Physical health (b) Psychological health (c) Social relationships (d) Environment. C1: Control on Day 1, C90: Control on Day 90, Y1: Yoga on Day 1, Y90: Yoga “intervention” Day 90

Table 1.

Evaluation of physiological markers changes in control and yoga groups before and after the intervention

Markers		Intervention group		Preintervention (day-0)		Postintervention (day-90)		t		P (≤0.05)
BMI		Control		23.70±3.46		24.04±3.44		−2.49		0.0232
		Yoga		22.3±2.27		21.29±1.89		2.27		0.0151
WC		Control		79.07±5.85		79.52±5.71		1.76		0.0947
		Yoga		76.78±4.85		76.32±4.38		1.45		0.1646
PSS score		Control		17.89±4.75		18.28±3.79		0.39		0.6990
		Yoga		19.44±4.32		18.61±2.48		−1.41		0.1760
WHO-BREF (D1)		Control		69.05±10.91		67.27±10.43		1.84		0.0830
		Yoga		68.71±7.94		75.33±7.92		−6.06		0.0000
WHO-BREF (D2)		Control		66.33±9.75		67.06±9.74		−0.48		0.6311
		Yoga		61.78±12.76		60.89±10.99		0.71		0.4819
WHO-BREF (D3)		Control		69.28±6.42		70.00±5.82		−1.41		0.1749
		Yoga		59.45±13.33		64.22±12.66		−1.81		0.0888
WHO-BREF (D4)		Control		60.00±13.64		58.61±15.54		−0.55		0.5848
		Yoga		68.56±13.86		67.17±12.62		0.56		0.5790

BMI: Body mass index, PSS: Perceived Stress Scale, WC: Waist circumference, WHO-BREF: World Health Organization-BREF

Assessment of immunological markers

The analysis of immune markers before and after the intervention is illustrated in Table 2, revealed distinct immunomodulatory effects, particularly in the Yoga group, shown in Figure 5. A significant reduction in IL-6 levels was observed in the Yoga group (from 12.91 ± 1.93 to 11.67 ± 1.01; P = 0.0436), indicating a decrease in systemic inflammation following yoga practice. Although the control group also showed a reduction in IL-6, it did not reach statistical significance (P = 0.0573), suggesting that yoga may have played a role in modulating this proinflammatory cytokine more effectively.

Table 2.

Evaluation of immunological markers changes in control and yoga groups before and after the intervention

Markers		Intervention group		Preintervention (day-0)		Postintervention (day-90)		t		P (≤0.05)
IL 6		Control		12.64±1.54		11.69±1.12		2.18		0.0573
		Yoga		12.91±1.93		11.67±1.01		2.35		0.0436
IL12		Control		89.18±17.16		58.05±15.35		1.78		0.0924
		Yoga		101.34±17.30		46.28±18.76		2.5		0.0336
INF-γ		Control		8.49±2.07		16.85±3.29		−9.18		0.0000
		Yoga		7.65±2.94		19.58±2.72		−13.3		0.0000
TNF-α		Control		40.47±5.56		38.69±7.49		0.84		0.4250
		Yoga		42.37±8.36		38.67±6.09		1.56		0.1526
CRP		Control		14.10±2.70		7.30±3.45		6.84		0.0001
		Yoga		14.7±3.20		6.25±3.29		8.23		0.0000

IL 6: Interleukin 6, IL 12: Interleukin 12, INF-γ: Interferon-gamma, TNF-α: Tumor necrosis factor alpha, CRP: C-reactive protein

Figure 5.

Pre and post assessment of Immunological Markers in both groups for inflammatory markers such as (a) IL6 (b) IL12 (c) INF (d) TNF (e) CRP. C1: Control on Day 1, C90: Control on Day 90, Y1: Yoga on Day 1, Y90: Yoga “intervention” Day 90. ***p < 0.001, **p < 0.01, *p< 0.05

Similarly, IL-12, a cytokine involved in the differentiation of T-helper cells and initiation of immune responses, significantly decreased in the Yoga group (from 101.34 ± 79.30 to 46.28 ± 28.76; P = 0.0336). The control group also showed a downward trend in IL-12 levels, but the change was not statistically significant (P = 0.0924). These results imply a potential anti-inflammatory or immuneregulatory effect of yoga, possibly contributing to immune homeostasis.

The most striking finding was the highly significant increase in IFN-γ levels in both groups, with a more pronounced effect in the Yoga group (from 7.65 ± 2.94 to 19.58 ± 2.72; P < 0.0001) compared to the Control group (from 8.49 ± 2.07 to 16.85 ± 3.29; P < 0.0001). IFN-γ is a key cytokine in antiviral defense and cell-mediated immunity. The greater increase in the Yoga group suggests that yoga may enhance immune surveillance and resilience through upregulation of Th1-type immune responses, which are essential in controlling viral infections such as COVID-19.

TNF-α levels, another indicator of inflammation, did not exhibit significant changes in either group (Yoga P = 0.1526; Control P = 0.4250), indicating that the intervention may not have substantially affected TNF-α-mediated pathways within the study duration.

A marked and statistically significant reduction in CRP levels, a sensitive marker of systemic inflammation, was observed in both groups. In the Yoga group, CRP levels declined from 14.7 ± 3.20 to 6.25 ± 3.29 (P < 0.0001), while in the control group, the reduction was from 14.10 ± 2.70 to 7.30 ± 3.45 (P = 0.0001). Although both groups presented substantial improvements, the greater magnitude of change in the Yoga group may indicate an added anti-inflammatory benefit of yoga practice, possibly mediated through stress reduction and autonomic regulation.

Postintervention analysis of markers in yoga and control groups

The postintervention comparison between the Yoga group (Y90) and the control group (C90) revealed key differences in immune markers, specific physiological and quality-of-life scores illustrated in Table 3. Among immune markers, IFN-γ levels were significantly higher in the Yoga group (19.58 ± 2.72) compared to the control group (16.85 ± 3.29), with a P = 0.0104, indicating a statistically significant enhancement in cell-mediated immune response potentially attributable to the yoga intervention. Although IL-12 levels were lower in the Yoga group, the difference was not statistically significant (P = 0.2012). Other inflammatory markers, including IL-6, TNF-α, and CRP, showed no significant differences between groups, suggesting a relatively stable inflammatory profile postintervention.

Table 3.

Comparison between postintervention yoga group with control on 90 days

Markers		Group-I (C90), mean±SD		Group-II (Y90), mean±SD		t		P (≤0.05)
IL 6		11.69±1.12		11.67±1.01		−0.0821		0.9350
IL 12		58.05±25.35		46.28±28.76		−1.3034		0.2012
INF-γ		16.85±3.29		19.58±2.72		2.7121		0.0104
TNF-α		38.69±7.49		38.67±6.09		−0.0079		0.9938
CRP		7.30±3.45		6.25±3.29		−0.9325		0.3576
PSS score		18.28±3.79		18.61±2.48		0.3126		0.7565
WHO-BREF (D1)		67.27±10.43		75.33±7.92		−3.88		0.0012
WHO-BREF (D2)		67.06±9.74		60.89±10.99		1.85		0.0829
WHO-BREF (D3)		70.00±5.82		64.22±12.66		1.77		0.0940
WHO-BREF (D4)		58.61±15.54		67.17±12.62		0.53		0.5963

IL 6: Interleukin 6, IL 12: Interleukin 12, INF-γ: Interferon-gamma, TNF-α: Tumor necrosis factor alpha, CRP: C-reactive protein, PSS: Perceived Stress Scale, WHO-BREF: World Health Organization-BREF, SD: Standard deviation

In terms of psychological outcomes, perceived stress scale (PSS) scores were slightly higher in the Yoga group, but the difference was not statistically significant (P = 0.7565), indicating comparable stress levels between both groups after 90 days.

Quality of life, assessed through the WHOQOL-BREF, demonstrated a significant improvement in Domain 1 (Physical Health) for the Yoga group (75.33 ± 7.92 vs. 67.27 ± 10.43; P = 0.0012), underscoring yoga’s beneficial impact on physical well-being. However, Domain 3 (Social Relationships), which may reflect temporary social limitations or altered self-perception due to heightened mindfulness, Domains 2 (Psychological Well-being) and 4 (Environmental Factors) did not show significant differences.

Discussion

The absence of definitive treatments during the early pandemic stages, enhancing immunity and preventing cytokine storms, emerged as critical objectives. Preventive strategies like vaccination, masking, and complementary practices like yoga have gained attention for their holistic benefits. Healthcare workers faced severe physical and mental health challenges during COVID-19, including depression, anxiety, post-traumatic stress disorder, burnout, poor work-life balance, social isolation, stigma, and reduced quality of life.[16] Yoga strengthens body and mind while boosting immunity and mental well-being, making it a valuable complementary treatment for COVID-19 recovery, particularly for long COVID-19 symptoms.[11] Yoga’s breathing exercises and meditation may help regulate stress, reduce inflammation, and strengthen immune function, potentially helping fight infections.[17,18] Yoga interventions varied widely in type, components, frequency, duration, and intensity.[19]

Growing evidence indicates that pro-inflammatory markers can directly influence emotional behavior, leading to increased interest in studying inflammation’s role in fear and anxiety disorders. Research has shown that elevated levels of inflammatory signals, including cytokines and CRP, are associated with these conditions.[20] The mechanism behind increased inflammation in phobias is stress response activation, prompting central and peripheral immune cells to release cytokines. Anxiety-related stress axis dysregulation – characterized by heightened sympathetic activity and reduced parasympathetic tone – may further exacerbate inflammation and intensify symptoms by directly impacting brain regions involved in fear and anxiety regulation, including the prefrontal cortex, insula, amygdala, and hippocampus.[20,21]

The 12-week yoga intervention of the present study demonstrated significant immunomodulatory effects, particularly in inflammatory marker regulation. The substantial reduction in IL-12 levels in the yoga group aligns with previous findings,[22] which reported yoga’s anti-inflammatory properties. The notable increase in IFN-γ levels in the yoga group suggests enhanced immune function, consistent with existing research showing yoga’s positive impact on immune response mechanisms.[23,24]

The significant decrease in CRP levels among yoga practitioners in comparison to controls is particularly noteworthy, as elevated CRP is associated with chronic inflammation and stress-related conditions.[25] While IL-6 and TNF-α showed minimal changes, the overall pattern of inflammatory marker modulation suggests that regular yoga practice may help regulate immune responses and reduce systemic inflammation in healthcare workers.

Research across 26 randomized controlled trials (RCTs) demonstrates yoga’s ability to boost immune function across diverse populations, including both healthy people and those with health conditions. The practice appears to decrease inflammation through its effects on immune markers, with the integrated approach of physical poses, breathwork, and relaxation techniques showing particular promise in addressing chronic inflammation.[26,27]

These findings support existing literature demonstrating yoga’s potential as a nonpharmacological intervention for improving immune function and reducing inflammation in high-stress populations.[27,28,29,30] The results indicate that incorporating yoga into healthcare workers’ routines could be an effective strategy for managing stress-induced inflammatory responses and enhancing overall immune health.[31]

The effects of a 12-week yoga intervention on physiological markers and quality of life among healthcare physicians during the COVID-19 pandemic, with a notable finding of a significant reduction in BMI (P = 0.0151) in the yoga group. This aligns with previous research indicating that yoga can aid in weight management by promoting physical activity, enhancing metabolic efficiency, and reducing stress-related eating behaviours.[32,33] However, other physiological markers, including waist circumference, did not exhibit statistically significant changes, suggesting that while BMI was affected, overall fat distribution remained relatively stable over the intervention period.

Regarding stress levels and quality of life, no significant changes were found in perceived stress scale (PSS), nor in most other than WHO-BREF D1 quality-of-life domains (physical health, psychological well-being, and environmental factors). This outcome may be attributed to the high baseline stress levels among physicians, exacerbated by the demands of the pandemic, which may have attenuated the measurable effects of yoga on stress reduction.[34] Nevertheless, a significant improvement was observed in the social relationships domain (WHO-BREF [D1]) with P < 0.0000, suggesting that yoga facilitated enhanced interpersonal interactions, possibly through mindfulness and community engagement components inherent in the practice.[35]

These findings are consistent with previous studies showing that yoga and mind–body interventions can lower proinflammatory cytokines and enhance immune resilience.[36,37] Given the heightened inflammatory responses observed in healthcare workers due to chronic stress exposure during COVID-19, these results highlight yoga’s potential as an adjunctive strategy for mitigating stress-related immune dysregulation.

While the improvements in BMI and immune markers are promising, the lack of significant changes in other quality-of-life indicators suggests that a longer duration or a more intensive yoga protocol may be required to yield broader psychosocial benefits. Moreover, given the unique stressors faced by physicians during the pandemic, integrating yoga with other stress management interventions, such as cognitive-behavioral strategies or structured peer-support programs, may enhance its effectiveness.[38]

The yoga intervention produced statistically significant reductions in proinflammatory cytokines, including IL-6, IL-12, and CRP, concurrent with a marked elevation in IFN-γ levels, demonstrating dual anti-inflammatory and immunomodulatory properties illustrated in Table 3 and Figure 5. These biomarker alterations suggest yoga’s potential as an adjunctive therapeutic modality for immune system regulation and stress resilience enhancement in healthcare personnel experiencing chronic occupational stress and elevated pathogen exposure, as observed during the COVID-19 pandemic.

Secondary outcomes included beneficial modifications in BMI and observable trends toward stress amelioration, corroborating yoga’s multifaceted contributions to physiological and psychological homeostasis. Quality-of-life assessments yielded heterogeneous results, with improvements observed across select domains while paradoxically showing decrements in self-reported physical health perceptions among intervention participants. This counterintuitive finding may represent enhanced somatic awareness or heightened self-assessment criteria rather than objective health deterioration.

The collective findings support the implementation of yoga-based interventions as evidence-based complementary therapeutic approaches for healthcare workforce wellness programs.

Conclusion

This pilot study suggests that a 12-week yoga intervention led to significant reductions in pro-inflammatory cytokines (IL-6, IL-12, and CRP) and a marked increase in IFN-γ, indicating enhanced immune regulation. BMI and physical health score improvements also reflect yoga’s potential to support overall well-being among HCPs experiencing high stress. While psychological outcomes and quality-of-life domains showed mixed results, the findings support further investigation into yoga as a complementary, nonpharmacological intervention for healthcare worker resilience. Larger, long-term studies are warranted to validate these preliminary findings.

Ethical statement

This study was conducted following approval from the Institutional Ethics Committee (AIIMS/IEC/21/42) and Clinical Trial Registry (CTRI/2021/03/032444), with independent informed consent obtained from participants for enrollment.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.