A randomized, double-blind, parallel and placebo-controlled clinical study to evaluate the efficacy and safety of KaraCalm™: a dietary supplement to support sleep and manage stress

Vrushali Gersappe; Krishna Rajendran; Keri Layton; Breanna  Guan; Ashish K. Gupta; Kudiganti Venkateshwarlu

doi:10.18203/2319-2003.ijbcp20241646

Authors

Vrushali Gersappe Sleep Specialist/General Psychiatrist, Redmond, WA, USA
Krishna Rajendran Karallief Inc, Boston, MA, USA
Keri Layton Department of Naturopathy, Whole Family Wellness, Winchester, MA USA
Breanna Guan Department of Naturopathy, Whole Family Wellness, Winchester, MA USA
Ashish K. Gupta Department of Naturopathy, Dr. BreAnna Guan, Boston, MA
Kudiganti Venkateshwarlu AyurLife Health Solutions, Bangalore, Karnataka, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20241646

Keywords:

KaraCalm™, Polyherbal formulation, Sleep quality, Stress reduction, Clinical trials

Abstract

Background: KaraCalm™ is a novel polyherbal formulation obtained from the combination of Valeriana officinalis extract, Passiflora incarnata extract, Ocimum sanctum extract, Ziziphus jujuba extract, Rosmarinus officinalis extract, and Nigella sativa extract. The objective of the present investigation was to assess the efficacy and safety of KaraCalm™ to manage stress and improve sleep in healthy subjects in a randomized, double-blind, placebo-controlled clinical study.

Methods: A total of 60 healthy volunteers were randomized into two groups, with 30 subjects in the KaraCalm™ group and 30 in the placebo group. Participants were asked to take KaraCalm™ 500 mg or placebo once daily for 56 days. As primary outcomes, sleep analysis was performed by using Actiwatch, while stress level was evaluated with the Perceived Stress Scale (PSS) scores from baseline to the end of the study period. Serum cortisol, and hs-CRP from baseline to the end of the study period were assessed as secondary endpoints.

Results: An increase in overall sleep quality was observed in the KaraCalm™ group compared to the placebo as measured by total sleep time, onset latency, wake after sleep onset minutes, and number of awakenings. There was also a reduction in PSS scores in the KaraCalm™ group from baseline to the end of the study, indicating reduced stress levels. A significant reduction in Serum cortisol and hs-C-reactive protein (CRP) levels in the KaraCalm™ group from baseline to the end of the study further supported the effectiveness of KaraCalm™ in reducing stress. There was no significant change in the safety analyses of the patients in the intervention group when assessed from the start of the study to the end.

Conclusions: KaraCalm™ can be considered a safe and effective dietary herbal Supplement to reduce stress and improve sleep quality.

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References

Head KA, Kelly GS. Nutrients and botanicals for treatment of stress: adrenal fatigue, neurotransmitter imbalance, anxiety, and restless sleep. Altern Med Rev. 2009;14(2):114-40.

Han KS, Kim L, Shim I. Stress and sleep disorder. Exp Neurobiol. 2012;21(4):141-50.

Bastien CH, Vallières A, Morin CM. Precipitating factors of insomnia. Behav Sleep Med. 2004;2(1):50-62.

Kim HK, Yang KI. Melatonin and melatonergic drugs in sleep disorders. Transl Clin Pharmacol. 2022;30(4):163-71.

Palagini L, Bianchini C. Pharmacotherapeutic management of insomnia and effects on sleep processes, neural plasticity, and brain systems modulating stress: A narrative review. Front Neurosci. 2022;16:893015.

DeMartinis NA, Kamath J, Winokur A. New Approaches for the Treatment of Sleep Disorders. In Advances in Pharmacology. Enna SJ, Williams M, Editors. Volume 57. Academic Press. 2009;187-235.

Ashton H. The diagnosis and management of benzodiazepine dependence. Curr Opinion Psychiatr. 2005;18 (3):249-55.

Davydov M, Krikorian AD. Eleutherococcus senticosus (Rupr. & Maxim.) Maxim. (Araliaceae) as an adaptogen: a closer look. J Ethnopharmacol. 2000;72(3):345-93.

Lerose V, Ponticelli M, Benedetto N, Carlucci V, Lela L, Tzvetkov NT, et al. Withania somnifera (L.) Dunal, a Potential Source of Phytochemicals for Treating Neurodegenerative Diseases: A Systematic Review. Plants (Basel). 2024;13(6):771.

Shinjyo N, Waddell G, Green J. Valerian Root in Treating Sleep Problems and Associated Disorders-A Systematic Review and Meta-Analysis. J Evid Based Integr Med. 2020;25:2515690X20967323.

Lopresti AL, Smith SJ, Metse AP, Drummond PD. A randomized, double-blind, placebo-controlled trial investigating the effects of an Ocimum tenuiflorum (Holy Basil) extract (HolixerTM) on stress, mood, and sleep in adults experiencing stress. Front Nutr. 2022;9:965130.

Saxena RC, Singh R, Kumar P, Negi MP, Saxena VS, Geetharani P, et al. Efficacy of an Extract of Ocimum tenuiflorum (OciBest) in the Management of General Stress: A Double-Blind, Placebo-Controlled Study. Evid Based Complement Alternat Med. 2012;2012:894509.

Nematolahi P, Mehrabani M, Karami-Mohajeri S, Dabaghzadeh F. Effects of Rosmarinus officinalis L. on memory performance, anxiety, depression, and sleep quality in university students: A randomized clinical trial. Complement Ther Clin Pract. 2018;30:24-8.

Lee HW, Yoon HS, Yang JJ, Song M, Lee JK, Lee SA, et al. Association of sleep duration and quality with elevated hs-CRP among healthy Korean adults. PLoS One. 2020;15(8):e0238053.

Hirotsu C, Tufik S, Andersen ML. Interactions between sleep, stress, and metabolism: From physiological to pathological conditions. Sleep Sci. 2015;8(3):143-52.

Mohan ME, Thomas JV, Mohan MC, Das S S, Prabhakaran P, Pulikkaparambil Sasidharan BC. A proprietary black cumin oil extract (Nigella sativa) (BlaQmax®) modulates stress-sleep-immunity axis safely: Randomized double-blind placebo-controlled study. Front Nutr. 2023;10:1152680.

Lee J, Jung HY, Lee SI, Choi JH, Kim SG. Effects of Passiflora incarnata Linnaeus on polysomnographic sleep parameters in subjects with insomnia disorder: a double-blind randomized placebo-controlled study. Int Clin Psychopharmacol. 2020;35(1):29-35.

Opstad K. Circadian rhythm of hormones is extinguished during prolonged physical stress, sleep and energy deficiency in young men. Eur J Endocrinol. 1994;131(1):56-66.

Thompson KI, Chau M, Lorenzetti MS, Hill LD, Fins AI, Tartar JL. Acute sleep deprivation disrupts emotion, cognition, inflammation, and cortisol in young healthy adults. Front Behav Neurosci. 2022;16:945661.

Lee A, Cho H. The effects caused by lavender and rosemary for salivary cortisol, stress levels and mood alteration. J Fashion Business. 2013;17(6):18-27.

Lichtenberger F, Rajendran K, Layton K, Lakshminarayan S, Krishnamurthy L, Deep DK. Assessment of KaraShieldTM properties in supporting the immune health of healthy subjects: a randomized, parallel, double-blind, placebo-controlled clinical study. Int J Basic Clin Pharmacol. 2024;13(1):1.