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BACKGROUND

  • Relaxium®: a novel formulation of various herbs and known sleep inducers has been developed.
  • Key ingredients include melatonin, L-tryptophan, gamma-aminobutyric acid (GABA) and several herbal extracts (e.g. Sensoril® ashwagandha, Valerest®, a blend of hops and valerian, Chamomile Passionflower).
  • Formulation is proprietary
  • Sponsor wanted to provide clinical evidence that Relaxium® Sleep is a bonafide sleep aid

STUDY OBJECTIVES

PRIMARY OBJECTIVE

  • To investigate the effect of Relaxium® Sleep administered prior to bedtime on sleep parameters, compared to placebo, in subjects with insomnia.

SECONDARY OBJECTIVE

  • To assess the safety and tolerability of Relaxium®.

STUDY DESIGN

  • Double-blind, Randomized, Placebo-controlled Parallel Group Design in subjects with insomnia.
  • A 1-week lead-in period with placebo capsules was followed by randomization to either placebo or Relaxium® in Week 2.
  • All medication was to be taken about 1 hour before bedtime.
  • Leeds Sleep Evaluation Questionnaires on the last 3-4 days of each treatment week.
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RESULTS

Click here to view the Relaxium® Sleep Clinical Trial
  • Compared to Placebo, Relaxium® was Associated with Statistically
    Significant Findings:
    • Fall Asleep Faster by 140%
    • Sleep Longer Without Interruption by 266%
    • Wake Refreshed and Alert by 69%
    • Improve Concentration by 80%

SAFETY

  • No adverse events were reported in the study

For more information contact us at: [email protected]