NCT00405041

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

Enrollment Period

1.3 years

First QC Date

November 21, 2006

Last Update Submit

April 8, 2008

Conditions

Herniated Disc

Outcome Measures

Primary Outcomes (1)

  • Measurements of herniated lumbar disc-related symptoms including sensorimotor neurological functions and pain sensations. And measurements of general quality of life based on the SF-36 questionnaire.

    Within 14 days of treatment and follow-up at 30 and 60 days after treatment

Study Arms (1)

A

EXPERIMENTAL
Dietary Supplement: Dietary supplement GVG 2

Interventions

Dietary supplement GVG 2DIETARY_SUPPLEMENT

2.670 g/day for 14 days

Also known as: GAVMATINE(TM)
A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women with diagnosis of herniated lumbar disc with nerve root compression, up to 3 months from beginning of symptoms.
  • Participants' age: 18 - 75 years.
  • Participants diagnosed by: i) computerized tomography CT or magnetic resonance imaging (MRI) when necessary; ii) neurological sensorimotor functional examination; iii) standard motor power scale; iv) pain sensation scales including the multidimensional tools: the Visual Analogue Scale of Pain Intensity for back and leg pain, the McGill Pain Questionnaire, and the Oswestry Disability Index; and v) Quality of life assessment based on the SF-36 questionnaire.
  • Women must be non-pregnant, non-lactating, or sterilized, or postmenopausal.
  • Participants must give a signed informed consent.

You may not qualify if:

  • Participants with any significant clinical, medical or surgical condition, such as: cardiovascular (including those with hypertension and treated with antihypertensive agents), pulmonary, hepatic, renal, immune, endocrine, metabolic, digestive, malignancy, or allergic.
  • Participants with low back pain emanating from causes other than herniated lumbar disc.
  • Participants with any neuromuscular diseases.
  • Participants with any musculoskeletal diseases.
  • Participants with any neurological diseases.
  • Participants with any history of alcohol or substance abuse within the last 2 years.
  • Participants with gastric ulcer history.
  • Participants who took any experimental drug within 90 days prior to screening.
  • Women who are pregnant or breast feeding.
  • Participants participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Souraski Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • Keynan O, Mirovsky Y, Dekel S, Gilad VH, Gilad GM. Safety and Efficacy of Dietary Agmatine Sulfate in Lumbar Disc-associated Radiculopathy. An Open-label, Dose-escalating Study Followed by a Randomized, Double-blind, Placebo-controlled Trial. Pain Med. 2010 Mar;11(3):356-68. doi: 10.1111/j.1526-4637.2010.00808.x.

    PMID: 20447305DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Samuel Dekel, M.D.

    Tel Aviv Souraski Medical Center

    STUDY DIRECTOR

  • Ory Keynan, M.D.

    Tel Aviv Souraski Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 29, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

IL(1)