DRKS00000326已完成3 期
Double-blind, randomised, multi-centre, placebo-controlled clinical trial to investigate the efficacy and safety of a combination of comfrey root extract plus methyl nicotinate versus a preparation containing methyl nicotinate alone or placebo in patients with conditions of acute upper or low back pain - KYT 62121/2008-01
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 379
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •At Visit 1, male or female patients have to fulfil the following inclusion criteria:
- •1. Age range 18-45 years.
- •2. Good general condition.
- •3. Written informed consent.
- •4. Acute back pain (either upper or low back pain), not in combination.
- •5. Sensitivity to algometric pressure on the site contralateral to the painful trigger point at least 2.5 N/cm2.
- •6. Back pain on active standardised movement of at least 50 mm on a 100 mm Visual Analogue Scale (VAS).
- •7. Basic value of the pressure algometry on the trigger point shall not exceed 50% of the respective value of the site contralateral to the painful trigger point.
排除标准
- •The patients must not meet any of the following exclusion criteria:
- •1. Upper or low back pain that is attributable to any identifiable cause (e. g. disc prolapse, spondylolisthesis, osteomalacia, or inflammatory arthritis).
- •2. Any recent trauma.
- •3. Any recent strains of the back muscles documented by the clinical evaluation and an amnesis.
- •4. Chronic back pain.
- •5. Likelihood of prolapsed spinal disc documented by clinical symptoms (pain irradiation to peripheral areas, paraesthesia, clinically detectable impairment of muscle strength of related areas).
- •6. Back pain caused by metabolic or neurological diseases documented by anamnesis (i.e. toxic neuropathy).
- •7. Diabetes Mellitus.
- •8. Risk factors for spinal infection.
- •9. Recent onset of bladder dysfunction or severe or progressive neurological deficit in the low extremity (as a possible indication of prolapsed disk).
- •10. Concomitant use of any anti-inflammatory drugs, heparinoids or analgesics including herbal preparations (glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis).
- •11. Analgesics or NSAIDs applied by any route of administration within 10 days before study entry or corticoid drugs applied by any route of administration within 60 days before study entry.
- •12. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication, that interferes with the conduct of the trial.
- •13. Known intolerance or hypersensitivity (allergy) to comfrey extract, peanut, soya, methyl nicotinate, parabenes or one of the other ingredients of the trial treatments, including known toxic reactions.
- •14. Local skin affections that do not allow the application of the test cream.
- •15. Participation in a clinical trial within the previous 30 days before enrolment in the trial, participation in this study before or simultaneous participation in another clinical trial.
- •16. Pregnancy or lactation period.
- •17. Women with childbearing potential without an effective contraceptive method.
- •18. Abuse of alcohol, medicaments or illicit drugs.
- •19. Any patient in the investigators opinion not considered suitable for enrolment.
- •20. Legal incapacity or limited legal capacity to give informed consent.
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