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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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Higher Numbers = better sleep,more alert upon awekening
*p value is difference between Placebo and Relaxium using repeated
measures test

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RESULTS

  • Compared to Placebo, Relaxium was Associated with Statistically
    Significant Findings:
    • Easier Time Falling Asleep (GTS)
    • Better Quality of Sleep (QOS)
    • More Alert & Refreshed Upon Awakening (BFW)

SAFETY

  • No adverse events were reported in the study