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临床试验/CTRI/2024/02/062473
CTRI/2024/02/062473尚未招募2 期

Clinical study of Irq al-Nasa (Sciatica) with therapeutic evaluation of Hijama bil shart (wet cupping) in its management: An open-label, block randomized, standard controlled clinical trial.

Central Council for Research in Unani Medicine New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Pain extending from back to Anterior thigh muscles.

研究概览

简要总结

Physicians since classical times were familiar with the malady sciatica. In the Unani system of medicine, Sciatica is known as Irq al-Nasa  also known as Langdi ka dard, Rengan baw.  Zakariya rhazi in his book Kitab ul mansoori mentioned that Irq al-Nasa is the pain which starts from hip and radiates to  thigh, sometimes even to calf muscles and legs.  The causative agents are Khilti-Dam(sanguine) or Khilt balgam ghaleez which gets accumulated in hip joint or a mixture of Khilti-balgam wa safra (phlrgm and bilious humor). It has been mentioned in book kitabul umda fil jarahat that for relieving severe pain Hijama bil shart (wet cupping) should be done. Sciatica is known as Sciatic nerve root entrapment or Sciatic nerve root pain or lumbosacral radicular syndrome or Lumbar radiculopathy. It signifies low back pain with radiation to ipsilateral leg, thereby implying pain radiating along sciatic nerve, which automatically contain fibres originating in L4-S2 roots. The prevalence of sciatica estimate vary widely 1.2-43%.  Sciatica is of two types Acute and Chronic. Most common etiology of sciatica is intrusion of L4,L5 or S1 nerve that is from the herniated disk and apparent as neuropathic pain affecting one side that is extending from the gluteal region down the leg to the foot.Conventional therapies given in sciatica for treatment include Analgesics, NSAIDs, Acupuncture Traction therapy, microdisectomy etc. Thses drugs and various surgical procedures are associated with certain side effects and many complications therefore, search for safe and effective is need of  on hour. Ancient physicians advocated Hijama bil shart in treatment of irq al-Nasa.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients between 18-65 years of age.
  • Patients irrespective of gender.
  • Pain radiating to lower limb either below or above the knee.
  • Pain in the range of 4-10 on VAS scale Clinically diagnosed patient of sciatica.
  • Willingness of the patient.

排除标准

  • Pregnancy and lactation Known case of spinal tumor or malignancy Known case of Rheumatoid arthritis or metabolic bone disease Incomplete or painful knee extension Uncontrolled diabetes Patients scheduled for surgery or who had previous surgery related to back Medicolegal issues Other con-current treatment or patients prior experience with a given treatment.
  • Patients suffering from bleeding disorders,anemia (severe anemia),HIV-AIDS,HepatitisB, Hepatitis C and patients on anticoagulants Patient requiring long term treatment.

结局指标

主要结局

Pain extending from back to Anterior thigh muscles.

时间窗: 0day, 14day, 28day and 42nd day

Radiating shooting pain from back to posterior thigh muscles

时间窗: 0day, 14day, 28day and 42nd day

Difficulty in movement

时间窗: 0day, 14day, 28day and 42nd day

次要结局

  • Straight leg raising test(Oswestry Disability Index)

研究者

发起方
Central Council for Research in Unani Medicine New Delhi
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Shameem Ahmad Rather

Regional Research Institute of Unani medicine srinagar

研究点 (1)

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