Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems

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Abstract

Background and objectives

SIVI is a standardized extract prepared using the aerial parts of Passiflora incarnata developed to enhance the quality of sleep. The objective of the present study was to the evaluate efficacy and safety of SIVI ( Passiflora incarnata extract) in the management of stress and sleep problems in Indian participants in a randomized, double-blind, placebo-controlled, clinical study.

Materials and methods

A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI ( Passiflora incarnata extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30.

Results

Passiflora incarnata extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI ( Passiflora incarnata extract) group compared to the placebo group on day 15 and day 30. SIVI ( Passiflora incarnata extract) did not show any adverse effects.

Conclusions

The results of the current study indicate that Passiflora incarnata extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia.

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Most cited references 18

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Short- and long-term health consequences of sleep disruption

Goran Medic, Micheline Wille, Michiel EH Hemels (2017)

Sleep plays a vital role in brain function and systemic physiology across many body systems. Problems with sleep are widely prevalent and include deficits in quantity and quality of sleep; sleep problems that impact the continuity of sleep are collectively referred to as sleep disruptions. Numerous factors contribute to sleep disruption, ranging from lifestyle and environmental factors to sleep disorders and other medical conditions. Sleep disruptions have substantial adverse short- and long-term health consequences. A literature search was conducted to provide a nonsystematic review of these health consequences (this review was designed to be nonsystematic to better focus on the topics of interest due to the myriad parameters affected by sleep). Sleep disruption is associated with increased activity of the sympathetic nervous system and hypothalamic–pituitary–adrenal axis, metabolic effects, changes in circadian rhythms, and proinflammatory responses. In otherwise healthy adults, short-term consequences of sleep disruption include increased stress responsivity, somatic pain, reduced quality of life, emotional distress and mood disorders, and cognitive, memory, and performance deficits. For adolescents, psychosocial health, school performance, and risk-taking behaviors are impacted by sleep disruption. Behavioral problems and cognitive functioning are associated with sleep disruption in children. Long-term consequences of sleep disruption in otherwise healthy individuals include hypertension, dyslipidemia, cardiovascular disease, weight-related issues, metabolic syndrome, type 2 diabetes mellitus, and colorectal cancer. All-cause mortality is also increased in men with sleep disturbances. For those with underlying medical conditions, sleep disruption may diminish the health-related quality of life of children and adolescents and may worsen the severity of common gastrointestinal disorders. As a result of the potential consequences of sleep disruption, health care professionals should be cognizant of how managing underlying medical conditions may help to optimize sleep continuity and consider prescribing interventions that minimize sleep disruption.

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The effects of stress on physical activity and exercise.

Matthew Stults-Kolehmainen, Rajita Sinha (2014)

Psychological stress and physical activity (PA) are believed to be reciprocally related; however, most research examining the relationship between these constructs is devoted to the study of exercise and/or PA as an instrument to mitigate distress. The aim of this paper was to review the literature investigating the influence of stress on indicators of PA and exercise. A systematic search of Web of Science, PubMed, and SPORTDiscus was employed to find all relevant studies focusing on human participants. Search terms included "stress", "exercise", and "physical activity". A rating scale (0-9) modified for this study was utilized to assess the quality of all studies with multiple time points. The literature search found 168 studies that examined the influence of stress on PA. Studies varied widely in their theoretical orientation and included perceived stress, distress, life events, job strain, role strain, and work-family conflict but not lifetime cumulative adversity. To more clearly address the question, prospective studies (n = 55) were considered for further review, the majority of which indicated that psychological stress predicts less PA (behavioral inhibition) and/or exercise or more sedentary behavior (76.4 %). Both objective (i.e., life events) and subjective (i.e., distress) measures of stress related to reduced PA. Prospective studies investigating the effects of objective markers of stress nearly all agreed (six of seven studies) that stress has a negative effect on PA. This was true for research examining (a) PA at periods of objectively varying levels of stress (i.e., final examinations vs. a control time point) and (b) chronically stressed populations (e.g., caregivers, parents of children with a cancer diagnosis) that were less likely to be active than controls over time. Studies examining older adults (>50 years), cohorts with both men and women, and larger sample sizes (n > 100) were more likely to show an inverse association. 85.7 % of higher-quality prospective research (≥ 7 on a 9-point scale) showed the same trend. Interestingly, some prospective studies (18.2 %) report evidence that PA was positively impacted by stress (behavioral activation). This should not be surprising as some individuals utilize exercise to cope with stress. Several other factors may moderate stress and PA relationships, such as stages of change for exercise. Habitually active individuals exercise more in the face of stress, and those in beginning stages exercise less. Consequently, stress may have a differential impact on exercise adoption, maintenance, and relapse. Preliminary evidence suggests that combining stress management programming with exercise interventions may allay stress-related reductions in PA, though rigorous testing of these techniques has yet to be produced. Overall, the majority of the literature finds that the experience of stress impairs efforts to be physically active. Future work should center on the development of a theory explaining the mechanisms underlying the multifarious influences of stress on PA behaviors.

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The impact of stress on body function: A review

Habib Yaribeygi, Yunes Panahi, Hedayat Sahraei … (2017)

Any intrinsic or extrinsic stimulus that evokes a biological response is known as stress. The compensatory responses to these stresses are known as stress responses. Based on the type, timing and severity of the applied stimulus, stress can exert various actions on the body ranging from alterations in homeostasis to life-threatening effects and death. In many cases, the pathophysiological complications of disease arise from stress and the subjects exposed to stress, e.g. those that work or live in stressful environments, have a higher likelihood of many disorders. Stress can be either a triggering or aggravating factor for many diseases and pathological conditions. In this study, we have reviewed some of the major effects of stress on the primary physiological systems of humans.

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Author and article information

Journal

Journal ID (nlm-ta): Cureus

Journal ID (iso-abbrev): Cureus

Journal ID (issn): 2168-8184

Title: Cureus

Publisher: Cureus (Palo Alto (CA) )

ISSN (Electronic): 2168-8184

Publication date (Electronic, pub): 20 March 2024

Publication date (Electronic, collection): March 2024

Volume: 16

Issue: 3

Electronic Location Identifier: e56530

Affiliations

[1 ] Department of Sanskrit Samhita Siddhant, DY (Dnyandeo Yashwantrao) Patil Deemed to be University School of Ayurveda, Navi Mumbai, IND

[2 ] Department of Kayachikitsa, KVTR (Karmvir Vyankatrao Tanaji Randhir) Ayurved College, Dhule, IND

[3 ] Department of Research, Target Institute of Medical Education and Research, Mumbai, IND

[4 ] Department of Rasashastra and Bhaishajya Kalpana, DY (Dnyandeo Yashwantrao) Patil Deemed to be University School of Ayurveda, Navi Mumbai, IND

[5 ] Department of Research, JK (Jairamdass Khushiram) Botanicals Private Limited, Navi Mumbai, IND

Author notes

Sanjay Tamoli Sr. targetinstitute@ 123456yahoo.com

Article

DOI: 10.7759/cureus.56530

PMC ID: 11026993

PubMed ID: 38646244

SO-VID: 62773dee-cc26-4c22-9a63-b06c4e3f871a

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date accepted : 20 March 2024

Funding

The study was funded by JK (Jairamdass Khushiram) Botanicals Private Limited, Navi Mumbai, India.

Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems

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Most cited references 18

Short- and long-term health consequences of sleep disruption

The effects of stress on physical activity and exercise.

The impact of stress on body function: A review

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