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临床试验/CTRI/2019/07/020046
CTRI/2019/07/020046招募中4 期

Effect of HijamaBishShart(wet cupping) and Zimad-i-Pudina in Irqunnasa(sciatica):A Comparative Clinical study

NIUm1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月25日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
•SBI (Sciatica Bothersomeness Index)

研究概览

简要总结

The term ‘Sciatica’ describes a symptom i.e, pain alongthe sciatic nerve pathway, rather than a specific condition, illness, or disease.It is generally caused by compression of lumbar nerve L4 or L5 or S1, S2, or S3or by compression of sciatic nerve itself. Pain typically occurs in the distribution of a dermatome & goesbelow the knee to the foot. It may be associated with neurological dysfunction,such as weakness . The pain is characteristically of a shooting type,quickly travelling along the course of the nerve.

It is one of thecommonest neuralgic pain creating difficulty & problem in activities of dailyliving. 2%-40% of people havesciatica at some point of time .It is most commonduring the age of 40s &50s and men are more frequently affected than women.

Despite of advancement, there is no specific treatmentapproach in modern system of medicine. The condition is managed by bed rest,physical therapy (directed exercise), opoids, muscle relaxants,NSAIDS, botulinum toxin injection, steroids, gabapentin, TENS, Surgery(disectomy) and alternative medicine.

In Unani system of medicine, Irqunnasa (sciatica)& its treatment has been describe by many physicians. According to Jalinoos(Galen),in Irqunnasa(sciatica) the morbid matter get accumulated in the joint.Therefore cupping will be beneficial for the same. According to IbneSina,prior to evacuation of morbid matter, strong purgatives should be avoided.Emesis is better than purgation, in addition anti-inflammatory ointment (Zimad)& irrigation can be used. In case, the condition remained unresolved wetcupping (Hijama) and Zimad can employed after mild laxatives.Keeping all these things in view, study l is planned to evaluate  the  effect of Hijama BishShart (wetcupping) and Zimad-e-Pudina in the patients of  Irqunnasa(sciatica).

Almostall ancient Unani physicians advocated  HijamaBishShart(wet  cupping) in the treatment of Irqunnasa(sciatica).Therefore,it is high time to evaluate the effect  of  HijamaBishShart(wet cupping) in the  management  of Irqunnasa(sciatica).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Clinically diagnosed cases of Irqunnasa(Sciatica) •Patients of either gender •Patient between 20-60 years of age •Weight more than 45 kg •Willingness to participate in the study and follow the instruction.

排除标准

  • •Pregnant woman & lactating mother •Spinal injury or deformity (congenital/acquired) •Any orthopaedic condition of hip joint restricting gait & movement •Systematic illness i.e. liver, kidney, cardiac, & pulmonary disease •Uncontrolled Diabetes mellitus, Severe Hypertension, bleeding disorders.

结局指标

主要结局

•SBI (Sciatica Bothersomeness Index)

时间窗: 0, 15th, 30th

•ODI (Oswestry Disability Index)

时间窗: 0, 15th, 30th

•Straight Leg Raising Test

时间窗: 0, 15th, 30th

•VAS (10 Points Likert’s Scale)

时间窗: 0, 15th, 30th

次要结局

  • Improvement in QoL(30th day)

研究者

发起方
NIUm
申办方类型
Research institution and hospital

研究点 (1)

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