INTRODUCTION:

Modern lifestyles contribute significantly to stress and mental fatigue, necessitating effective interventions. According to the IPSOS World Mental Health Day Report 2024¹, stress has become a global health concern, with 62% of individuals across 31 countries reporting stress levels that impact their daily life. Türkiye reports the highest stress levels at 76%, while Japan reports the lowest at 44%.

Women (66%) tend to experience higher stress levels than men (58%), with Gen Z females being particularly vulnerable—40% of them report feeling persistently sad or hopeless for extended periods.

Mental health remains a primary global concern, with 45% of respondents identifying it as one of the most pressing health issues, surpassing cancer (38%) and stress (31%). The impact of stress is particularly severe among younger generations, with 54% of Gen Z and 47% of Millennials experiencing stress levels that prevent them from attending work.

These statistics highlight the widespread burden of stress and its significant impact on individuals' daily lives, work productivity, and overall health. To fully understand the ramifications of stress and the need for effective interventions, it is essential to examine its underlying physiological mechanisms.

Stress is a physiological and psychological response triggered by external or internal stimuli perceived as threats^2,3. The hypothalamic-pituitary-adrenal (HPA) axis plays a crucial role in the stress response. Upon encountering a stressor, the hypothalamus signals the pituitary gland to release adrenocorticotropic hormone (ACTH), which in turn stimulates the adrenal glands to produce cortisol, the primary stress hormone^4,5. Elevated cortisol levels prepare the body for a "fight-or-flight" response by increasing glucose availability, modulating immune function, and affecting mood and cognition⁶.

In addition to cortisol, other key hormones involved in stress regulation include adrenaline and norepinephrine, secreted by the adrenal medulla. These catecholamines enhance alertness, elevate heart rate, and redirect energy toward essential bodily functions⁷. However, chronic stress leads to dysregulation of these pathways, resulting in cognitive impairment, mood disorders, and increased risk of metabolic and cardiovascular diseases⁸.

The autonomic nervous system (ANS) is also implicated in stress regulation, with the sympathetic nervous system (SNS) driving the acute stress response and the parasympathetic nervous system (PNS) facilitating recovery. Persistent activation of the SNS without adequate PNS modulation can lead to sustained stress and anxiety disorders⁹.

Given the increasing burden of stress-related disorders, there is an urgent need for effective solutions to mitigate stress and enhance mental well-being¹⁰. Pharmacological interventions, such as anxiolytics and antidepressants, are often associated with dependency and side effects, underscoring the demand for natural alternatives¹¹. Nutraceuticals, derived from plant-based compounds, have gained attention for their adaptogenic and anxiolytic properties, offering a safer and holistic approach to stress management^12,13. While this study was designed to evaluate perceived stress relief, it is important to recognize the close relationship between stress and anxiety. Chronic, unresolved stress can progress into anxiety disorders, where fear and worry persist even after the stressful situation has ended. Given this overlap, the present work primarily examines stress reduction but may also provide preliminary insights into mitigating anxiety-like symptoms associated with prolonged stress exposure.

"Restore Your Peace" is a nutraceutical formulation composed of extracts of Matricaria chamomilla (Chamomile), Hypericum perforatum (St. John's Wort), Centella asiatica (Gotu Kola), Cucurbita pepo (Pumpkin seed oil), Withania somnifera (Ashwagandha), Valeriana wallichii (Valerian), and Moringa oleifera (Moringa) in the form of sugar free dark chocolate apricot centered dragees. These ingredients have been traditionally used for their anxiolytic, adaptogenic, and neuroprotective properties.

· Matricaria chamomilla (Chamomile): Chamomile has been widely studied for its anxiolytic properties. Studies have demonstrated that chamomile extract can significantly reduce symptoms of generalized anxiety disorder^14,15. It acts via modulation of gamma-aminobutyric acid (GABA) receptors, thereby promoting relaxation and reducing stress levels¹⁶. Additionally, chamomile possesses anti-inflammatory and antioxidant properties that further contribute to its calming effects¹⁷.

· Hypericum perforatum (St. John's Wort): St. John's Wort is known for its antidepressant effects, primarily attributed to its ability to inhibit serotonin reuptake¹⁸. Several clinical trials have shown that St. John's Wort is as effective as standard selective serotonin reuptake inhibitors (SSRIs) in treating mild to moderate depression, with fewer side effects^19-21. The active compounds, hypericin and hyperforin, play a crucial role in modulating neurotransmitter levels²².

· Centella asiatica (Gotu Kola): Gotu Kola has been traditionally used for cognitive enhancement and stress reduction^23,24. Research indicates that it modulates neurotransmitter levels and promotes neuroprotection, thereby reducing anxiety and improving mental clarity²⁵. Additionally, it has been shown to enhance synaptic plasticity and increase brain-derived neurotrophic factor (BDNF) levels, which support cognitive resilience²⁶.

· Cucurbita pepo (Pumpkin Seed Oil): Pumpkin seed oil is rich in tryptophan, a precursor of serotonin, which is crucial for mood regulation^27,28. Studies suggest that its consumption can improve sleep quality and alleviate symptoms of depression^29,30. Also, it contains enzymatic and non enzymatic antioxidants³¹. Furthermore, pumpkin seed oil contains magnesium and zinc, which have been linked to improved neurological function and reduced stress levels³².

· Withania somnifera (Ashwagandha): Ashwagandha is a well-known adaptogen that helps the body resist stress³³. Research indicates that it reduces cortisol levels, thereby mitigating the physiological effects of chronic stress^34,35. Additionally, Ashwagandha has been found to improve endurance, reduce inflammation, and enhance overall cognitive function, making it a comprehensive stress-relief solution³⁶.

· Valeriana wallichii (Valerian Root): Valerian root has been extensively studied for its sedative and anxiolytic effects³⁷. It enhances GABA activity, leading to improved relaxation and sleep quality³⁸. Furthermore, valerian root has been found to reduce sleep latency and improve deep sleep phases, making it an effective natural remedy for insomnia and stress-induced sleep disturbances³⁹.

· Moringa oleifera (Moringa Leaf): Moringa is known for its high antioxidant content, which helps combat oxidative stress⁴⁰. Studies suggest that it has neuroprotective properties and may help in reducing anxiety and depression-like behaviors⁴¹. In addition, Moringa contains essential amino acids and vitamins that support brain function and overall well- being^42-44.

The objective of this study is to investigate the efficacy of "Restore Your Peace," a candyceutical formulation containing bioactive compounds with scientifically supported anxiolytic and adaptogenic properties. Previous studies on the individual ingredients of this formulation suggest beneficial effects on stress modulation, neuroprotection, and improved cognitive function. However, the synergistic impact of these ingredients in a combined formulation remains largely unexplored.

Furthermore, the study aims to bridge the gap between traditional knowledge and scientific validation by employing rigorous clinical methodologies to assess the effects of "Restore Your Peace." By examining its impact on multiple stress-related parameters, including focus, mood, physical tension, problem-solving ability, and sleep quality, this research provides crucial insights into the potential role of nutraceuticals in holistic stress management.

MATERIALS AND METHODS:

Study Design: A single-arm, open-label clinical study was conducted to evaluate the effects of "Restore Your Peace" nutraceutical on stress relief and cognitive function. The study was designed following Good Clinical Practice (GCP) guidelines the principles laid by Declaration of Helsinki.

Participants: A total of 95 healthy volunteers, aged 18–55 years, were recruited through screening based on predefined inclusion and exclusion criteria. Participants with chronic illnesses, psychiatric disorders, or those taking medications that could influence cognitive function were excluded. Stress levels were evaluated during screening using a validated scale, and only participants with a stress level greater than 2 were selected for the study. The average stress level of the selected participants was 3.12. Informed consent was obtained from all participants before enrolment. (Perceived stress Scale, PSS-10), where an average score of 3.12 indicated moderate stress at baseline. A sample size of 95 participants was chosen to provide adequate preliminary statistical power for detecting moderate effect sizes in self reported outcomes, while ensuring feasibility within the available study resources and timeline. This number also allows subgroup analyses by baseline stress levels.

Intervention: Each participant received 15 doses of "Restore Your Peace" (3.5g each) over 15 consecutive days. Participants were instructed to consume the dragees at the onset of a stress trigger to assess its immediate effect. The nutraceutical was administered in a standardized dosage format, and compliance was monitored through daily intake records. The extracts used were standardized to their key bioactive constituents, and the 3.5g dosage was selected based on preliminary palatability, safety, and efficacy testing, ensuring optimal delivery of actives.

Outcome Measures: Primary outcomes included subjective assessments of stress-related parameters such as calmness, physical tension, focus, energy levels, problem-solving ability, stress coping ability, mood, and sleep quality. These were recorded using a validated five-point Likert scale. Additionally, the onset of action duration was measured to determine the time taken for the formulation to exhibit noticeable effects after consumption. Furthermore, the formulation was evaluated for dependency potential to ensure long-term safety and efficacy. To assess dependency potential, participants were asked at day 15 whether they experienced any cravings, compulsion to increase dosage, or discomfort upon discontinuation. This was recorded through a structured self report questionnaire.

Data Collection and Statistical Analysis: Data were collected through structured self-reported questionnaires at baseline, mid-study (day 7), and post-intervention (day 15). Descriptive statistics were used to summarize the data. Paired t-tests and repeated measures ANOVA were employed to analyze changes across time points. Correlation analyses were conducted to assess inter-parameter relationships, and subgroup analyses were performed to identify response variations across demographic groups.

Safety and Compliance Monitoring: Adverse events were monitored throughout the study, and participants were instructed to report any discomfort or side effects. Compliance rates were calculated based on daily intake logs, with participants achieving ≥80% adherence included in the final analysis.

RESULTS:

Based on the collected data, The formulation demonstrated a rapid onset of action, with effects being observed within 30–45 minutes post-consumption. Following is the detailed observation of results.

Descriptive Statistics: The mean values for the key parameters assessed in the study are as follows: Statistical tests (paired t-test, repeated measures ANOVA) confirmed significance of these changes (all p <0.05).

· Feeling Calm and Relaxed: 3.89 ± 0.92

· Reduced Physical Tension: 4.02 ± 0.87

· Improved Focus and Clarity: 3.75 ± 0.98

· Improved Energy: 3.68 ± 0.94

· Improved Problem-Solving Ability: 4.12 ± 0.88

· Handled Situations Better: 3.91 ± 0.89

· Improved Mood: 3.80 ± 0.91

· Sleep Quality: 3.85 ± 0.93

Correlation Analysis: Significant correlations (p < 0.05) were observed between multiple parameters:

· Feeling Calm and Relaxed vs. Reduced Physical Tension (r = 0.65)

· Improved Focus and Energy Levels (r = 0.72)

· Improved Problem-Solving Ability vs. Handling Situations Better (r = 0.61)

· Improved Mood vs. Sleep Quality (r = 0.58) These correlations suggest a strong interdependence between cognitive and emotional well-being parameters. However, given the single arm design, these correlations reflect associations between variables rather than causality attributable to the intervention.

Trend Analysis:

· Problem-solving ability demonstrated an increasing trend over time, suggesting improved cognitive resilience among participants.

· Focus and confidence improved steadily across the study duration, reinforcing the cognitive benefits of the formulation.

· Physical tension showed initial fluctuations but demonstrated an overall decline in reported stress levels by the end of the study.

· Participants with higher baseline stress levels showed more significant improvements across all parameters compared to those with lower baseline stress levels.

Subgroup Analysis:

· High Performers (Top 25%): Reported an average problem-solving score of 4.65 and mood improvement of 4.50, indicating greater cognitive and emotional benefits in this group.

· Low Performers (Bottom 25%): Reported lower but still notable improvements, with problem-solving ability averaging at 3.25 and mood at 3.10.

Safety and Compliance:

· No serious adverse events were reported.

· Mild gastrointestinal discomfort was noted in two participants but resolved without intervention.

· Compliance rates exceeded 85%, confirming adherence to the intervention protocol.

These results collectively demonstrate that "Restore Your Peace" significantly enhances cognitive and emotional well-being while maintaining an excellent safety profile. Additionally, 95% of participants reported no dependency on the product, reinforcing its safety for long-term use. It should be noted, however, that the 15 day study duration only provides an initial safety signal; longer-term follow-up is necessary to confirm sustained safety.

DISCUSSION:

The findings from this study provide strong evidence supporting the efficacy of "Restore Your Peace" in enhancing mental well-being and stress management. The rapid onset of action observed within 30–45 minutes post-consumption indicates that the nutraceutical formulation exerts its effects in a timely manner, making it a suitable intervention for acute stress episodes. This is particularly relevant given that many pharmacological interventions for stress and anxiety require prolonged administration before noticeable effects occur. Future studies should validate this observation through pharmacokinetic measurements.

The statistically significant improvements observed across all measured parameters suggest that the formulation exerts a comprehensive influence on both psychological and physiological aspects of stress regulation. The strong correlations between relaxation, reduced physical tension, improved problem-solving ability, and enhanced focus underscore the interconnected nature of cognitive and emotional states. These findings align with existing literature on the individual ingredients, reinforcing their established roles in neuroprotection, anxiolysis, and cognitive enhancement.

One of the most notable aspects of this study is the high level of safety associated with the product. The absence of serious adverse events and the minimal incidence of mild gastrointestinal discomfort suggest that "Restore Your Peace" is well tolerated. Furthermore, the lack of dependency reported by 95% of participants is particularly important, as many conventional anxiolytics and antidepressants carry risks of withdrawal symptoms and long-term dependency.

A key strength of this study is its real-world applicability. By instructing participants to consume the formulation at the onset of stress triggers, this study provides insight into how the product performs in daily life scenarios rather than under controlled experimental conditions alone. This approach enhances external validity and supports the formulation's potential as a practical intervention for stress relief in various populations.

Despite these promising findings, there are several limitations to consider. First, the study was conducted as an open-label trial without a placebo control, which may introduce bias in self-reported measures. Future randomized, double-blind, placebo-controlled trials are warranted to further validate the findings. Additionally, while the study included a diverse age range (18–55+ years), further research is needed to assess its efficacy in more specific subpopulations, such as individuals with clinically diagnosed anxiety disorders or chronic stress conditions. One key limitation is the absence of a placebo control group, which prevents attribution of effects solely to the intervention. Future randomized, double-blind, placebo- controlled studies are warranted. Additionally, future studies should include objective biomarkers such as salivary cortisol or heart rate variability to strengthen the self-reported outcomes.

The observed trends in subgroup analyses indicate that participants with higher baseline stress levels exhibited more substantial improvements, suggesting that the formulation may be particularly beneficial for individuals experiencing moderate to high stress. This aligns with the adaptogenic properties of ingredients such as Withania somnifera and Centella asiatica, which have been shown to exert greater effects under higher physiological stress conditions.

Overall, this study highlights the significant potential of "Restore Your Peace" as a safe and effective nutraceutical for stress management. The formulation’s ability to enhance cognitive function, alleviate physical tension, and promote emotional well-being positions it as a viable alternative or adjunct to pharmacological treatments. Future research should focus on mechanistic studies to elucidate the exact biochemical pathways involved in the observed effects and long-term studies to assess sustained benefits and safety over extended use.

CONCLUSION:

The findings from this study underscore the potential of "Restore Your Peace" as an effective, safe, and non-addictive nutraceutical intervention for stress management and cognitive enhancement. The statistically significant improvements in calmness, focus, mood, and problem-solving ability highlight the formulation’s ability to positively modulate both psychological and physiological stress responses. The rapid onset of action within 30–45 minutes suggests its suitability for acute stress relief, while the absence of dependency in 95% of participants supports its long-term usability without the risks associated with conventional pharmacological interventions.

The observed correlations between cognitive and emotional parameters suggest a synergistic interaction between the bioactive components of the formulation. Ingredients such as Withania somnifera, Centella asiatica, and Hypericum perforatum have well-documented adaptogenic and neuroprotective properties that likely contribute to these beneficial effects. Additionally, the reduction in physical tension further reinforces the holistic nature of this nutraceutical in mitigating stress-related symptoms.

Despite the promising findings, future placebo-controlled, double-blind studies with larger sample sizes are necessary to further substantiate these results. Moreover, mechanistic studies exploring the biochemical pathways involved in the formulation’s action would provide deeper insights into its efficacy. Long-term studies assessing sustained benefits and potential cumulative effects would also be valuable.

In conclusion, "Restore Your Peace" represents a scientifically validated, natural alternative for stress relief and mental well-being. Its combination of rapid efficacy, broad-spectrum cognitive benefits, and high safety profile makes it a compelling option for individuals seeking a non-pharmacological approach to stress management provides preliminary evidence as a natural alternative.

ACKNOWLEDGEMENT:

The authors express their sincere gratitude to all the participants who volunteered for this study. We extend our appreciation to the research staff, data analysts, and laboratory personnel for their contributions to data collection and analysis. Special thanks to the Institute of Chemical Technology, Matunga, Mumbai for their support in facilitating this research.

CONFLICT OF INTEREST:

The authors declare that there are no conflicts of interest related to this study. The study was conducted independently, and there was no external influence from commercial entities or organizations that could have affected the results or interpretations.

STATEMENT OF INFORMED CONSENT:

All participants provided written informed consent before their inclusion in the study. The purpose, methodology, potential risks, and benefits of the study were thoroughly explained to the participants before obtaining consent. Participants were informed of their right to withdraw from the study at any time without consequences.

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Received on 10.03.2025 Revised on 05.07.2025

Accepted on 16.09.2025 Published on 03.04.2026

Available online from April 06, 2026

Research J. Pharmacy and Technology. 2026;19(4):1711-1717.

DOI: 10.52711/0974-360X.2026.00246

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.