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临床试验/CTRI/2026/03/106049
CTRI/2026/03/106049尚未招募2 期

Clinical study to evaluate the therapeutic effects of Safuf e Chobchini in the management of Waja al Unaq Cervical Spondylosis An open label block randomized standard control study

Central Council for Research in Unani Medicine CCRIUM1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年4月1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
52
试验地点
1

研究概览

简要总结

The term Cervical spondylosis describes chronic degenerative lesions of single or multiple intervertebral discs with formation of osteophytes in related vertebral bodies. Cervical spondylosis is a leading cause of musculoskeletal disability in humans.Most people with spondylotic changes of the cervical spine on radiographic imaging remain asymptomatic with 25% of individuals under the age of 40, 50% of individual over the age of 40, and 85% of individuals over the age of 60 showing some evidence of degenerative changes. The most frequently affected levels are C6-C7 followed by C5-C6. Symptomatic Cervical spondylosis most commonly present as neck pain.In the general population, the point prevalence of neck pain ranges from 0.4% to 41.5%, the 1- year incidence ranges from 4.8% to 79.5%, and lifetime prevalence may be as high as 86.8%.According to the Global Burden of Disease 2019, neck pain ranked second only to back pain as a cause of total years lived with disability (YLD) and the fourth leading cause of disability -adjusted life years (DALYs). In general neck pain rankings were also higher in developed regions of the worldThe international incidence of Cervical spondylosis is 2.5 cases per 1000 population. While in India, incidence is 3.5 cases per 1000 population. It is determined by the age of 70 approximately 100 percent of males, 96 percent of females will have some degree of Cervical spondylosisThe primary risk factor and contributor or the incidence of Cervical spondylosis is age-related degeneration of the intervertebral disc and cervical spinal elements. Degenerative changes in surrounding structures, including the uncovertebral joints, facet joints, posterior longitudinal ligament (PLL), and ligamentum flavum all combine to cause narrowing of the spinal vasculature, and nerve roots can be compressed, resulting in the three clinical symptoms in which Cervical spondylosis presents: axial neck pain, Cervical myelopathy and Cervical radiculopathy.

As for as the Unani  system is concerned, the term Waja al Unaq is not mentioned at all in any classic text, but most of the eminent physicians used the term Waja al Mafasil to represent all types of joint pain, and also named them accordingly like Niqris (Gout), Waja al-Warik (ischail pain), Irq al-Nasa (Sciatica), Waja al-Rakaba (knee pain) etc. Similarly, when Waja al-Mafasil occurs in Fiqrate Unaq and causes neck pain , it is known as Waja al Unaq (Cervical spondylosis), because here  Waja stands for Pain and Unaq stands for neck. So cervical spondylosis is also described as Waja al- Unaq  a type of Waja al-Mafasil, and treated as per the line of treatment of Waja al Mafasil as described in Unani text.

Presently there is no definite cure for Cervical spondylosis nor are there any pharmacological agents available that definitely affect the underlying pathological process. In Allopathic system of medicine the disease is usually treated by using NSAIDs, corticosteroids, antidepressants, cervical epidural steroid injection, surgery and certain physiotherapy regimens like TENS, tractions, and cervical collars etc. Though the use of these drugs provide significant improvement in symptoms of Cervical spondylosis on short term basis, but their prolonged use may induce side effects. However, the potential for serious side effects such as gastrointestinal bleeding and ulceration, exacerbation of hypertension and fluid retention; concerns about their renal and cardiovascular safety particularly in older individuals with co-morbidities limit their use. While in severe cases of Cervical spondylosis surgery is done which is too costly with unusual eventualities.Therefore, search for safe and effective herbal formulation is neecd of an hour.To ascertain the effectiveness of Safuf-i- Chobchini , the current study named  Clinical study to evaluate the therapeutic effects of Safuf e Chobchini in the management of Waja al Unaq (Cervical Spondylosis): An open label, block randomized, standard control study  has been designed

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

  • 1.Patients between 18 to 65 years of age.
  • 2.Patient irrespective of gender.
  • 3.Clinically and radiologically diagnosed patients of Cervical spondylosis.
  • 4.Patients who have agreed to sign the informed consent form and are willing to follow up as per the study protocol.

排除标准

  • 1.History of cervical trauma or injury.
  • 2.Known case of uncontrolled Diabetes, Hypertension, impaired Renal and Hepatic functions.
  • 3.Known case of cervical myelopathies.
  • 4.Pregnant and lactating women.
  • 5.Patient who refuse to give written consent for the study and unwillingness to come for regular follow up as described in the study plan.

研究者

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

Dr Zaffar Hussain

Regional Research Institute of Unani Medicine (RRIUM), Srinagar

研究点 (1)

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