Relaxium®

A Study to Evaluate the Effects
of RELAXIUM®
Sleep in Subjects
With Sleep Disorders

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.

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

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