EUCTR2006-003621-87-DE进行中（未招募）不适用
Double-blind, placebo-controlled, randomised, parallel-groups, multi-centre clinical trial for the evaluation of efficacy and safety of an ointment of comfrey extract in comparison to placebo in the treatment of acute upper or low back pain
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age range 18-60 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. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 anamnesis.
- •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/corticoid drugs applied by any route of administration within 10 days of study entry or corticoid drugs applied by any route of administration within 60 days of study entry.
- •12. Any other concomitant treatment or medication, that interferes with the conduct of the trial.
- •13. Known intolerance or hypersensitivity (allergy) to the trial treatments, including known toxic reactions.
- •14. Local skin affections that do not allow the application of the test ointment.
- •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 investigator’s opinion not considered suitable for enrolment.
- •20. Legal incapacity or limited legal capacity to give informed consent.
研究者
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