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A new clinical trial suggests that a proprietary herbal extract reduces anxiety and stress in healthy but overweight women. The randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted to evaluate the safety and efficacy of the anxiety-reducing reducing effects of Relora®, a patented propriety blend of two herbal extracts. 1
The trial enrolled 40 healthy, overweight, physically active 25-50 year-old women with anxiety. Each subject took a 250 mg dose of Relora 3 times per day for 6 weeks. A primary outcome of the trial showed that the herbal formulation significantly reduced anxiety and stress, as measured within the design of the trial. An intent-to-treat analysis indicated that the Spielberger Trait Total and Anxiety Index scores improved significantly, and by twice as much with Relora® as with placebo (p=0.047). The Relora® group also had twice as much average reduction in sleep latency (11 minutes, p=0.012) as the placebo group (5 minutes, p=0.147). Sleep latency is the time required to fall asleep once a subject puts his or her head on a pillow and intends to sleep; reducing this time normally indicates a reduction in nervousness and anxiety.
Relora is made by Next Pharmaceuticals of Carlsbad, California, a producer of proprietary herbal formulations (more at www.nextpharmaceuticals.com). Relora consists of magnolia bark extract (Magnolia officinalis, a traditional Chinese herb) and a patent-pending extract from Phellodendron amurense.
The results of the yet-unpublished trial were presented in a poster session at the annual Federation of American Societies for Experimental Biology (FASEB) Conference in San Francisco on April 2nd. The results were presented by Douglas S. Kalman, MS, RD, FACN, director of clinical research, at Miami Research Associates, Miami, Florida, the contract research organization that conducted the trial.
[Editor’s Note: The American Botanical Council has published this brief summary of this trial as a newsworthy item for ABC members and stakeholders. ABC advises readers that the data from unpublished clinical trials are subject to potential revision when these data are evaluated by peer reviewers of medical, pharmacy, nutrition and other professional journals.]
Reference
1. Krieger DR, Schwartz H, Parlato C, et al. A Randomized Double Blind Placebo Controlled Clinical Trial Evaluating a Dietary Supplement Product (Relora) in the Management of Stress in Healthy Adults. Poster presentation at Federation of American Societies for Experimental Biology (FASEB) Conference, San Francisco, CA, Apr 2, 2006.
Source
Next Pharmaceuticals. Relora® Significantly Reduces Stress, Anxiety
Study Findings to be Presented at the FASEB in San Francisco [press release]. Carlsbad, CA: Next Pharmaceuticals, Mar 30, 2006.
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