NCT02640417

Nucleotides and B Vitamins in the Treatment of Low Back Pain

Avaliação clínica-terapêutica Comparativa em Lombalgias de Etiologia Traumato-compressivas Utilizando-se Vitaminas do Complexo B e nucleotídeos

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Fundação Educacional Serra dos Órgãos · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Nucleotides + B12	Oral treatment with either Nucleotides + Vitamin B12
DRUG	B Vitamins	Oral treatment with vitamins B1, B6, and B12

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-03-01
• Completion: 2018-10-01
• First posted: 2015-12-29
• Last updated: 2019-04-19