A randomized comparative clinical study to evaluate the efficacy of Trayodashanga Guggulu and Sahacharadi Kwatha with and without Greeva Basti in the management of Greevasandhigata Vata w.s.r. to Cervical Spondylosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Relief in Shoola (pain) in patients suffering with Greevasandhigata Vata.
研究概览
简要总结
Cervical Spondylosis is a chronic degenerativeprocess of the cervical spine that affects the vertebral bodies and intervertebraldisks of the neck and may progress into disk herniation, bone spur formation,compression of the spinal cord, or cervical spondylotic myelopathy.
Cervical Spondylosis is a degenerative joint disorder with the symptomsof pain, restricted movements of the neck and joint instability. It is a slowprogressive disorder and occurs usually after the age of 40 years.
Cervical spondylosis is not explained detailsin Ayurveda but condition can be managed using principle of Ayurveda.
The symptomatology of Sandhigata Vataas described in Ayurveda classics is as follows- Hantisandhigatah(loss of function), Shoola(pain), Aatopa. Vatapurnadriti Sparsha, Shotha, Prasarana AakunchanaSavedana.
So Greevasandhigata Vata can becorrelated with Cervical Spondylosis due to similarity in the clinicalfeatures.
As mentioned earlier it isincreasing health burden in present scenario. Various attempts have been made by many researchers to find out effectivesolution for treatment of Cervical Spondylosis. The drugs used to treat Cervical Spondylosis in modern medical science have several sideeffects and have chance of pain again after certain time of termination ofmedication. The surgical treatment for Cervical Spondylosis is very costly and not a standard solution.Many Ayurveda researcher have tried to find out solution of CervicalSpondylosis treatment, but still couldnot be established any standard effective guideline. So there is need to assessthe efficacy of drugs mentioned in Ayurveda classics and must be revalidated.
Aim:
To compare the efficacy of *‘Trayodashang Guggulu & Sahacharadi Kwatha’*with and without Greeva Bastiin the management of ‘GreevasandhigataVata’ (Cervical Spondylosis).
Objectives:
To evaluate the clinical efficacy of *‘Trayodashang Guggulu & Sahacharadi Kwatha’*with and without Greeva Bastiin the management of ‘GreevasandhigataVata’ (Cervical Spondylosis).
Nullhypothesis:
There is no difference between the effects of Trayodashang Guggulu & SahacharadiKwatha**’ with and without GreevaBasti inthe management of Greevasandhigata Vata w.s.r. to Cervical Spondylosis.
Alternativehypothesis:
There is significant difference between theeffects of Trayodashang Guggulu &Sahacharadi Kwatha**’ with and without GreevaBasti inthe management of Greevasandhigata Vata w.s.r. to Cervical Spondylosis.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient willing to participate in trial. 2.The patients in the age group of
- •70 years of either sex. 3.The patients having clinical sign and symptoms of Greevasandhigata Vata w.s.r. to Cervical Spondylosis. 4.The patients having chronicity of disease less than 5 years. 5.The patients having radiological finding of Cervical Spondylosis.
排除标准
- •1.Recent cervical, spinal, or shoulder surgery or implanted instrumentation or previous surgery for cervical spondylotic myelopathy.
- •2.Patients with long term history of steroid and cytotoxic treatment.
- •3.Patients having concomitant illness like uncontrollable Hypertension, Diabetes Mellitus etc.
- •4.Patients with evidence of malignancy.
- •5.Patient participated in any clinical trial within last six months.
- •6.Pregnant or lactating women.
结局指标
主要结局
Relief in Shoola (pain) in patients suffering with Greevasandhigata Vata.
时间窗: 30 days
次要结局
- Improvement in Neck Disability Index.(30 days)