Avaliação clínica-terapêutica Comparativa em Lombalgias de Etiologia Traumato-compressivas Utilizando-se Vitaminas do Complexo B e nucleotídeos
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Adverse Event Occurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders, at least 18 years of age
- •Clinical presentation of acute lumbago (<3 days of initial visit, with and without functional alteration, with medium intensity: Visual Analog Pain score between 20mm and 80mm
- •Female subjects should be post-menopausal or using birth control
- •Subjects must sign informed consent document
排除标准
- •Intolerance to any component of the study treatments
- •Pregnancy or breastfeeding
- •Need for surgical treatment
- •Use of other analgesic drugs
- •dyshematopoiesis or coagulation disorder
- •Gastric or intestinal ulcer
- •Gastrointestinal, cerebrovascular, or other bleeding
- •Creatinine >3x% reference range
- •Urea, ALT, AST, or GGT >2x% reference range
- •Any other disease or condition that in the investigator's opinion should exclude the subject from the study
研究组 & 干预措施
Nucleotides + B12
Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment
干预措施: Nucleotides + B12 (Drug)
B vitamins
Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment
干预措施: B Vitamins (Drug)
结局指标
主要结局
Adverse Event Occurrence
时间窗: Throughout 60 day treatment period
Percentage of subjects in each treatment group presenting with adverse events
次要结局
- Finger-to-Floor Distance(Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment))
- Visual Analog Pain Scores(Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment))
- Low back pain Questionnaire(Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment))
研究者
Marco Antonio Naslausky Mibielli
Professor and Chairman of Orthopedics
Fundação Educacional Serra dos Órgãos