Open Label Prospective Clinical Study to Assess the Efficacy of Cotyledon umbilicus Prescribed According to “The Encyclopedia of Pure Materia Medica†for Managing the Pain of Sciatica
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement of the score obtained (pre and post treatment) from Modified Roland Morris Disability scale.
研究概览
简要总结
This study is a prospective, non-randomized, open-label, single arm, unicentric, interventional clinical study to assess the efficacy of Cotyledon umbilicus in alleviating the pain of sciatica prescribed according to the symptoms mentioned in "The Encyclopedia of Pure Materia Medica". The study will evaluate the extend of improvement in pain due to sciatica using Modified Roland Morris Disability Scale as an assessment scale and to enlist additional symptoms verified during the study. The primary outcome will be according to the scores obtained (pre and post treatment) from the Modified Roland Morris Disability Scale. The secondary outcome will be assessing the efficacy of Cotyledon umbilicus in alleviating the pain of sciatica according to the symptoms mentioned in The Encyclopedia of Pure Materia Medica and enlisting additional symptoms verified during the study.
NULL HYPOTHESIS (H0) – There will be no significant improvement in pain in the cases of sciatica after prescribing Cotyledon umbilicus based on symptoms mentioned in “The Encyclopedia of Pure Materia Medica†by T. F. Allen.
ALTERNATIVE HYPOTHESIS (H1) – There will be significant improvement in pain in the cases of sciatica after prescribing Cotyledon umbilicus based on symptoms mentioned in “The Encyclopedia of Pure Materia Medica†by T. F. Allen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient giving consent for the study. 2.Patient having minimum 3 symptoms of the following of Cotyledon umbilicus mentioned in “The Encyclopedia of Pure Materia Medica†by T. F. Allen as follows: ✓ Aching bruised pain all over the lower limbs. She can scarcely walk for aching in the limbs, legs feel heavy and sore. ✓ Pain and stiffness of the right hip, going off after a walk, in the evening. Shooting pain, sudden and sharp, in the right infra gluteal region, felt principally on walking in the open air. ✓ Great aching of the hip joint, relieved by moving about. Continual soreness of the hip and thigh, posteriorly. ✓ Aching in the left thigh, posteriorly. Aching in the back part of the left thigh, with numbness. Stringing pain under the left gluteal maximus, in the region of great sciatic nerve 3.Diagnosed cases taking treatment from other system of medicine having no relief seeking homoeopathic treatment. 4.Undiagnosed cases will be enrolled after confirming the following criteria:.
- •âœ“ Straight Leg Raise (SLR) positive. ✓ Patient presenting with clinical features of pain radiating down the back to the extremities with positive result of one or more neurological examination indicating nerve root tension or neurological deficit and numbness of the limbs. ✓ Xray of Lumbosacral Region (PA and Lateral View).
排除标准
- •1.Females those are pregnant or lactating.
- •2.Patient refusing or not willing to give consent for the study.
- •3.Patient suffering from severe systemic diseases.
- •4.Cases requiring emergency/surgical intervention.
- •5.Patient from other pharmacological intervention and are not willing to leave it.
结局指标
主要结局
Improvement of the score obtained (pre and post treatment) from Modified Roland Morris Disability scale.
时间窗: Pre score will be taken at the baseline of treatment and post scores will be assessed at the end of 3 months using Modified Roland Morris Disability Scale.
次要结局
- To assess the efficacy of Cotyledon umbilicus in alleviating pain of sciatica prescribed according to the symptoms mentioned in "The Encyclopedia of Pure Materia Medica" and enlist additional symptoms verified during the study.(12 months)
研究者
Dr Shayantan Kumar Das
Dr MPK Homoeopathic Medical College Hospital and Research Centre