A Phase 4 interventional study of Nucleotides + B12 and B Vitamins in Low Back Pain, sponsored by Fundação Educacional Serra dos Órgãos. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-19.
Sponsored by Fundação Educacional Serra dos Órgãos · Phase 4, Interventional, and Treatment
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12.
This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12. The aim of this study is to evaluate and compare the therapeutic effect of the combination of nucleotides + vitamin B12 with that of the combination of vitamins B1, B6 and B12 in low back pain. Safety and efficacy will be monitored throughout the treatment period. Subjects will be randomized in a double-blind fashion to either treatment group.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 300 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Fundação Educacional Serra dos Órgãos is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment
Drug: Nucleotides + B12
Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment
Drug: B Vitamins
Oral treatment with either Nucleotides + Vitamin B12
Also known as: Group A
Oral treatment with vitamins B1, B6, and B12
Also known as: Group B
Adverse Event Occurrence
Percentage of subjects in each treatment group presenting with adverse events
Time frame: Throughout 60 day treatment period
Low back pain Questionnaire
Percentage of subjects in each treatment group presenting improvement of \>5 points in Questionnaire scores
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Visual Analog Pain Scores
Percentage of subjects in each treatment group presenting improvement of VAS pain scores in relation to pretreatment
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
Finger-to-Floor Distance
Percentage of subjects in each treatment group presenting improvement of \>3cm in finger to floor distance in relation to pretreatment values
Time frame: Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)
No study locations are listed for this record.
The record gives a start of Mar 2016, a primary completion of Mar 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Fundação Educacional Serra dos Órgãos