Our Research

Background

  1. Relaxium®: a novel formulation of various herbs and known sleep inducers has been developed.
  2. 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).
  3. Formulation is proprietary
  4. Sponsor wanted to provide clinical evidence that Relaxium® Sleep is a bonafide sleep aid

Study Design

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

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®.

Results

Click here to view the Relaxium® Sleep Clinical Trial

  1. Compared to Placebo, Relaxium® was Associated with Statistically

Safety

  1. No adverse events were reported in the study
SIGNIFICANT FINDINGS:
  1. Fall Asleep Faster by 140%
  2. Sleep Longer Without Interruption by 266%
  3. Wake Refreshed and Alert by 69%
  4. Improve Concentration by 80%
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