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临床试验/CTRI/2021/02/031581
CTRI/2021/02/031581尚未招募2 期

Efficacy of FasÌ£d (venesection) in the management of ‘IrqunnasÄ (Sciatica) - A Randomized Controlled Study

National Institute of Unani Medicine NIUM1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月3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
40
试验地点
1
主要终点
1Straight Leg Raising Test

研究概览

简要总结

Sciatica refers to pain or discomfort associated with sciatic nerve. Injury to or pressure on the sciatic nerve can cause the characteristic pain of sciatica: a sharp or burning pain that radiates from the lower back or hip, possibly following the path of the sciatic nerve to the foot. It is one of the commonest neuralgic pain creating difficulty and problems in activities of daily living. The overall incidence of this condition is approximately between 13- 40 % and the malady has the potential to become chronic and intractable with major socioeconomic implication.Sciatica is usually treated by the conventional therapies either pharmacologically or surgically or sometimes, both. these therapies are associated with certain side effects and complications; therefore, search for a safe and effective regimen is the need of the hour. There is a disease in Unani system of medicine known as **‘**IrqunnasÄ its signs and symptoms mimick almost completely with sciatica. Hence, any approach for treating **‘**IrqunnasÄ will also be beneficial for sciatica. For **‘**IrqunnasÄ there are a no. of different kinds of regimens given  which are more effective with less adverse effects and at the same time cost effective like HÌ£ijÄma (Cupping), IrsÄl-i-‘Alaq (Leech therapy), Dalk (massage), Ä€bzan (Sitz Bath) and  FasÌ£d (Venesection). Almost all great Unani physicians advocated FasÌ£d in the treatment of **‘**IrqunnasÄ . Therefore, it is high time to evaluate the efficacy and safety of FasÌ£d in the  management  of **‘**IrqunnasÄ.

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
20.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinically diagnosed cases of ‘IrqunnasÄ (SLR 30-70ï‚°)15 2.Pain in the range of 4 to 9 on VAS.
  • 3.Both genders 4.Patients between 20 to 55 years of age 5.Hb13gm/dl or more 6.Patients willing to take part in the study.

排除标准

  • 1.who fail to give consent for the trial and follow up 2.Pregnancy, Lactation 3.Systemic illness e.g. cancer, liver, kidney, cardiac and pulmonary diseases 4.Bleeding tendencies 5.Hypotension (Below 100/60mmHg) 6.Spinal injury or deformity (Congenital / Acquired) 7.Any orthopedic condition of hip joint restricting gait and movement 8.Patients Positive cases of HIV or HBsAg.

结局指标

主要结局

1Straight Leg Raising Test

时间窗: 14th day | 28th day

2VAS (visual analogue scale)

时间窗: 14th day | 28th day

次要结局

  • 1ODI (Oswestry Disability Index)16(2SBI (Sciatica Bothersomeness Index))

研究者

发起方
National Institute of Unani Medicine NIUM
申办方类型
Research institution and hospital

研究点 (1)

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