Clinical study of Cervical Spondylosis (waja al-Unuq) with therapeutic evaluation and safety of Habb Waja al Mafasil in its management
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- relief in signs and symptoms of cervical spondylosis
研究概览
简要总结
Cervical Spondylosis is defined as spinal canal and neural foraminal narrowing in cervical spine secondary to multifactorial degenerative changes. This is one of the most common degenerative disorders of the spine affecting 95% of patients by the age of 65 years. The majority of people with spondylosis are asymptomatic. Patients who are asymptomatic tend to be older than 40 years and present with 3 types of symptoms neck pain, cervical radiculopathy and/or cervical myelopathy. The neck pain is either acute or chronic and often without identifiable precipitating event. Cervical spondylosis stands for degenerative arthritis, osteoarthritis of the cervical vertebrae and related tissues. It is characterized by degeneration of the intervertebral discs and osteophytes formation. It is often asymptomatic but may cause radiating neck pain into back of head, shoulder, arm or may be the source of headache in posterior occipital region.
In classical Unani literature cervical spondylosis is mentioned as neck pain and has been described as Waja ul Unuq type of waja ul Mafasil , derrangement of humours and accumulation of morbid humours are among its causes.
Cervical Spondylosis is such a common and disabling condition preventing patients from certain physical activities and it is felt that it should be managed through multiple approaches that are pharmacological, non pharmacological and surgical . The use of NSAIDs and corticosteriods provide significant improvement in symptoms but their prolong use may induce side effects , similarly most of the patients avoid surgery due to complications associated with it. Unani scholars have successfully treated neck pain through various methods and claimed them effective but thie effectiveness needs scientific validation. Hence the trial entitled Clinical Study of Cervical Sponydlosis with Therapeutic evaluation and safety of Habb waja ul Mafasil in its management has been selected
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 20 and 70 years of age.
- •Male, Female and transgender -Clinically diagnosed patients of cervical spondylosis -Patients who have agreed to sign the informed consent form and follow up the protocol.
排除标准
- •Patients below 20 and above 70 years.
- •Trauma Local wound and infection over neck.
- •Psychomotor syndrome Patients with history of systemic diseases like, diabetes, cardiovascular diseases, impaired renal and hepatic functions, HIV, T.B and COPD.
- •Patients who refuse to give the written consent for the study.
- •Pregnancy and lactating women.
- •Any of them not covered under inclusive criteria.
结局指标
主要结局
relief in signs and symptoms of cervical spondylosis
时间窗: 30 days
次要结局
- Haematological,biochemical and radiological assessment(30 days)