Herniated DiscPhase 2/3NCT00405041
Randomized Controlled Study to Assess the Efficacy of a Dietary Ingredient in Patients With Herniated Lumbar Disc Compression
A Phase 2/3 study testing Dietary supplement GVG 2 in people with Herniated Disc, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Herniated Disc
- What is being tested?
- Dietary supplement GVG 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2006to Apr 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Center, Phase II/III, Randomized, Double-Blind, Placebo-Controlled, Study, to Assess the Therapeutic Efficacy of a Dietary Ingredient in Patients With Herniated Lumbar Disc Causing Nerve Root Compression
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.
Read the 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.
- Conditions
- Herniated Disc
- Being tested
- Dietary supplement GVG 2
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement GVG 2Dietary supplement
Also called GAVMATINE(TM)
2.670 g/day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Dietary Supplement: Dietary supplement GVG 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 14 days of treatment and follow-up at 30 and 60 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herniated DiscStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Assaf-Harofeh Medical Center
- Investigators
- Samuel Dekel, M.D., Study director, Tel Aviv Souraski Medical CenterOry Keynan, M.D., Principal investigator, Tel Aviv Souraski Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405041
- Sponsor's protocol ID
- TASMC-06-OK-06-203-CTIL
- Other IDs
- 107/06
- Status last verified
- Apr 2008
- First submitted
- 21 Nov 2006
- Last updated
- 10 Apr 2008
- Results posted
- No
Publications
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.
PubMed 20447305
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Center, Phase II/III, Randomized, Double-Blind, Placebo-Controlled, Study, to Assess the Therapeutic Efficacy of a Dietary Ingredient in Patients With Herniated Lumbar Disc Causing Nerve Root Compression
- ClinicalTrials.gov ID
- NCT00405041
- Acronym / sponsor ID
- TASMC-06-OK-06-203-CTIL
- Conditions
- Herniated Disc
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- Nov 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 29 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Dietary supplement GVG 2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement GVG 2Also: GAVMATINE(TM)2.670 g/day for 14 days | Dietary supplement | A |
Primary outcome
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.
Time frame: Within 14 days of treatment and follow-up at 30 and 60 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2008.
- Derived from this study: PubMed 20447305Keynan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Dekel, M.D. study director
Tel Aviv Souraski Medical Center
Ory Keynan, M.D. principal investigator
Tel Aviv Souraski Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dietary supplement GVG 2 in people with Herniated Disc, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Within 14 days of treatment and follow-up at 30 and 60 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00405041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.