CTRI/2024/03/064253尚未招募2 期
A pilot clinical trial to determine the safety and effectiveness of coded Siddha formulations Nuflm-1 capsule, Spln -2 softgel and Rudn oil -3 in the management of cervical disc disorder with radiculopathy (M50.10) and Sciatica (M54.3) - NI
il0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Males or females, ages 18 to 65, are able and willing to provide written informed consent to participate in the study.
- •Leg pain radiating to or below the knee in a dermatomal pattern, diagnosed as being due to sciatica or lumbar or lumbosacral radiculopathy, the onset of which occurred 2 to 12 weeks prior to initiation of study treatment.
- •Leg pain severity on a screening Categorical Pain Intensity Rating (for the prior 3 days period) of at least 4 in the numerical rating scale. Leg pain should be more severe than back pain on Numerical rating scale of pain at screening.
- •Positive straight leg raising (SLR) test.
- •Pain, paresthesia or numbness in the upper-limb with cervical or periscapular pain for less than 3 months.
- •At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motoneuron lesion to the upper-limb.
- •Positive responses to at least 3 of the 4 following clinical tests: Spurling Test, Upper
- •Limb Tension Test, Cervical Distraction Test, and less than 60° of cervical rotation
- •on the impaired side.
排除标准
- •Known or suspected serious spinal pathology.
- •Prior surgery to the cervico - thoracic spine.
- •Signs of superior motor neuron impairments.
- •Cervical spine injection in the previous four weeks.
- •Current use of steroidal anti-inflammatory drugs.
研究者
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