TCTR20141027001已完成未知
A single-blind randomized controlled trial of AVS023 poly-herbal formula for Acute low back pain: a pilot study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 29
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Men and women aged 18–65 years, who diagnosed with nonspecific acute LBP.
- •2.The eligible patients had moderate to severe acute LBP at baseline (score ≥ 4 on an 11-point numerical rating scale [NRS]; 0 = no pain,” 10 = pain as very bad as patient can imagine”) for less than 72 hours.
- •3.Participants were informed by written consent.
排除标准
- •1.Patients who had a history of lumbar and spinal accident in former 1 year or lumbosacral surgery.
- •2.Patients who had a history of osteoporosis, immunodeficiency, diabetes mellitus, hypertension, cardiovascular disease, thyroid, endocrine gland disease and asthma.
- •3.Patients who have a current active peptic-duodenal ulcer, gastro-esophageal reflux disease (GERD).
- •4.Patients who had a history of epilepsy or recurrent seizures; have current active liver disease (abnormal liver function test or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevated more than 2 times of upper normal limit).
- •5.Patients who had creatinine clearance (CrCl) less than 50 ml/min or any significant renal disease.
- •6.Patients who have blood pressure over 140/90 mmHg; known hypersensitivity to Ibuprofen or AVS023 or herbal and pollen grain.
- •7.Patients who concomitant use of phenytoin, rifampicin, propranolol, theophylline, corticosteroids, other anti-inflammatory, anticoagulant and antiplatelet in a current medication.
- •8.Pregnancy or lactating.
- •9.Patients who required treatment with an opioid analgesic.
- •10.Patients who prior either drugs NSAIDs, AVS023 or any analgesics, anti-inflammatory and muscle relaxants treatment within 1 week.
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