The product is a combination of extracts from Valerian (Valeriana officinalis), purple passionflower (Passiflora incarnata), Holy basil (Ocimum sanctum), Jujube (Ziziphus jujuba), Rosemary (Rosmarinus officinalis) and black cumin/ black seed (Nigella sativa). The product was developed by Boston-based Karallief Inc.
Data published in the International Journal of Basic & Clinical Pharmacology indicated that eight weeks of supplementation with the herbal extract blend led to a 64% reduction in high sensitivity C-Reactive Protein (hs-CRP), a marker of inflammation.
The supplement was also associated with a 39% increase in total sleep time, equivalent to gaining over two hours of sleep, a 70% decrease in the time to fall asleep and a 53% reduction in the number of awakenings after first falling asleep, reported scientists from Karallief Inc, Massachusetts-based Whole Family Wellness and AyurLife Health Solutions in India.
The researchers also reported a 40% decrease in perceived stress levels scores and a 30% decrease in serum cortisol.
“KaraCalm showed remarkable results in the clinical studies using objective datapoints—like the Actiwatch sleep measurements and blood markers like cortisol and hs-CRP,” said Dr. Vrushali Gersappe, MD, a sleep specialist and lead author on the paper.
“Very few dietary supplements are clinically studied and even the ones that are clinically studied usually only have subjective questionnaire and not objective data.”
Study details
Sixty healthy adults were recruited to take part in the 56-day randomized, double-blind, parallel, placebo-controlled study. The participants were randomly assigned to consume either placebo or 500 mg of the botanical extract combination for eight weeks.
The results showed that, according to sleep analysis performed using Actiwatch, the KaraCalm group experienced improved total sleep time, onset latency, wake after sleep onset minutes and number of awakenings, compared to placebo.
In addition, stress levels, evaluated using the Perceived Stress Scale (PSS), were significantly decreased after supplementation, compared to placebo, the researchers reported.
“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,” they added.
Importantly, the researchers also reported no relevant adverse events or side effects, “thus indicating that KaraCalm was well tolerated and safe for consumption.”
“Therefore, based on the overall results, it appears that KaraCalm is a safe and effective dietary herbal supplement to reduce stress and improve sleep quality,” they concluded.
Source: International Journal of Basic & Clinical Pharmacology
2024, Volume 13, Number 4, doi: 10.18203/2319-2003.ijbcp20241646
“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”
Authors: V. Gersappe et al.
