CTRI/2019/05/018946尚未招募2 期
"A Randomized Controlled clinical Study To Evaluate The Efficacy Of Hijamah Bil Shart in Irq-un-Nasa (Sciatica)"
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relief in pain due to sciatica
研究概览
简要总结
This proposed open, randomized, prospective clinical study will be conducted on the diagnosed patients of Sciatica according to defined inclusion and exclusion criteria. 30 patients in group A and 30 patients in group B will allocated randomly. Hijamah at Warik and Fakhiz will be done in group A patients, whereas Hijamah at Saaq and Kaab will be done in group B patients on Day 0, Day 14 and Day 28. The assessment will be done on 0 day, 14th day, 28th day and 42nd day for improvement in pain, disability and quality of life. This study will validate the efficacy of Hijamah therapy in the management of Sciatica and will compare the efficacy as per the sites of Hijamah.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Already diagnosed patients of sciatica presenting with all or some of the following signs and symptoms Unilateral leg pain greater than low back pain radiating towards leg/ foot/toes Positive straight-leg-raising sign Numbness and/ or tingling sensation in the same distribution Pain intensity score of 30 -60 mm on a 100-mm visual analog scale (VAS) Willingness to accept wet cupping intervention.
排除标准
- •Pregnant and lactating women.
- •Patients of previous back surgery/ lumbar spine surgery.
- •Patients of spinal tumors, gross/fixed developmental deformity, cauda equine or vertebral fracture Patients of bleeding disorders Patients of anaemia (Hb<10gm%) Patients taking any other conservative treatment for sciatica (NSAIDS, corticosteroids, physiotherapy, acupuncture etc.) Patients with malignancy or any liver, kidney or heart disease Patients of of inherited neuropathy or neuropathy attributable to other causes like hypothyroidism, vitamin B12 deficiency etc.
- •Motor weakness/Muscle wasting Patients suffering from Psychiatric disorders HIV/AIDS, HCV and HBsAg positive patients History of stroke, severe hypertension and uncontrolled diabetes mellitus Unwilling to participate in the study.
结局指标
主要结局
Relief in pain due to sciatica
时间窗: 0 day, 42 day
次要结局
- Improvement in Disability and Quality of life(0 day, 42 day)
研究者
研究点 (1)
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