Randomized Controlled Study to Assess the Efficacy of a Dietary Ingredient in Patients With Herniated Lumbar Disc Compression
Condition: Herniated Disc
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the study is to evaluate the efficacy of a neuroprotective dietary
      supplement in patients suffering from herniated lumbar disc causing nerve root compression.
    

Detailed description: 
      Herniated lumbar discs exert pressure on nerves in the spine leading to pain, numbness,
      tingling and weakness of the leg, sometimes termed "sciatica". This syndrome affects about
      1-2% of the population, usually at the age of 30 to 50 (the prime working years) leading to
      significant economic impact.

      Injuries of nerves can lead to degeneration of the parent nerve cells, the neurons. Recent
      evidence indicates that herniated lumbar disc exerts mechanical pressure on spinal nerve
      roots that leads to local ischemia and inflammation resulting in nerve injury (i.e.
      neurotrauma). This neurotrauma can lead to degeneration of the corresponding nerve cells
      (dorsal root ganglia sensory neurons and spinal cord motoneurons), resulting in persistent
      deficits in motor functions, sensation and pain. Enhancing nerve cell survival capabilities
      (i.e., neuroprotection), therefore, should prove a novel therapeutic strategy for slowing or
      preventing degeneration of neurons resulting from herniated lumbar disc compression. Yet, in
      spite of an intensive search, clinically effective and safe neuroprotective therapeutic is
      not available.

      The active ingredient in the dietary/medical food supplement under study was discovered to be
      an efficacious neuroprotective agent. The original findings, confirmed by laboratories
      throughout the world, indicate that the active compound is unique as it acts at multiple
      molecular targets to exert its robust neuropeotective effects.

      The active ingredient is found in many plant, fish and meet foodstuffs and is being used and
      sold as a food supplement and nutraceutical. Its use as a neuroprotective agent is patented
      and thus, it constitutes an ideal candidate for neuroprotective treatment in herniated lumbar
      disc and other spine skeletal pathologies causing nerve compression.

      The safety of the dietary supplement under study was clearly demonstrated in a recent
      clinical trial. Results of the trial demonstrated improvement in the general health status
      and indicated efficacy in alleviating symptoms in participants with herniated lumbar disc and
      other spine skeletal pathologies causing nerve root compression.

      The present study is randomized, double-blind, placebo-controlled trial designed to ascertain
      the therapeutic efficacy of the dietary supplement in participants with herniated lumbar disc
      causing nerve damage symptoms. The study is being conducted in two medical centers in Israel.
      Eighty participants are presently being recruited and are screened under strict inclusion and
      exclusion criteria. Eligible individuals are invited to participate after signing a detailed
      informed consent prior to beginning of the study. The participants are being assigned
      randomly to receive either the dietary ingredient or placebo in a blind fashion whereby
      neither the treating physician nor the participant are aware of the type of treatment.
    

Intervention name(s): Dietary supplement GVG 2
Intervention type(s): Dietary Supplement
Intervention description(s): 2.670 g/day for 14 days
Other intervention name(s): GAVMATINE(TM)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment