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

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dc.contributor.authorGersappe, V.en_US
dc.contributor.authorRajendran, K.en_US
dc.contributor.authorLayton, K.en_US
dc.contributor.authorGuan, B.en_US
dc.contributor.authorGupta, A. K.en_US
dc.contributor.authorVenkateshwarlu, K.en_US
dc.date.accessioned2024-09-24T06:13:58Z
dc.date.available2024-09-24T06:13:58Z
dc.date.issued2024-08
dc.description.abstractBackground: 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.en_US
dc.identifier.affiliationsSleep Specialist/General Psychiatrist, Redmond, WA, USAen_US
dc.identifier.affiliationsKarallief Inc, Boston, MA, USAen_US
dc.identifier.affiliationsDepartment of Naturopathy, Whole Family Wellness, Winchester, MA USAen_US
dc.identifier.affiliationsDepartment of Naturopathy, Whole Family Wellness, Winchester, MA USAen_US
dc.identifier.affiliationsDepartment of Naturopathy, Dr. BreAnna Guan, Boston, MAen_US
dc.identifier.affiliationsAyurLife Health Solutions, Bangalore, Karnataka, Indiaen_US
dc.identifier.citationGersappe V., Rajendran K., Layton K., Guan B., Gupta A. K., Venkateshwarlu K.. 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. International Journal of Basic & Clinical Pharmacology. 2024 Jul; 13(4): 475-485en_US
dc.identifier.issn2319-2003
dc.identifier.issn2279-0780
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/226762
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber4en_US
dc.relation.volume13en_US
dc.source.urihttps://doi.org/10.18203/2319-2003.ijbcp20241646en_US
dc.subjectKaraCalm™en_US
dc.subjectPolyherbal formulationen_US
dc.subjectSleep qualityen_US
dc.subjectStress reductionen_US
dc.subjectClinical trialsen_US
dc.titleA 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 stressen_US
dc.typeJournal Articleen_US
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