CompletedPhase 2/3

Randomized Controlled Study to Assess the Efficacy of a Dietary Ingredient in Patients With Herniated Lumbar Disc Compression

Israel79 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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

Trial details

NCT IDNCT00405041

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2008-03

View on ClinicalTrials.gov More Herniated Disc trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.