Randomized Control Trial on Erandamula Ghanavati With Nasya In Manyagraha With Special Reference To Cervical Spondylosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1)To study effect of oral administration of Erandamula Ghanavati with Anu Taila Nasya particularly on Oswestry Neck Disability Questionnaire and to compare it’s effect with the effect of oral administration of Panchatiktaghrita Guggulu with Anu Tail Nasya.
研究概览
简要总结
Cervical spondylosis is a general term for age ralated wear and tear affecting the spinal disksin neck.
Spondylosis is caused from years ofconstant abnormal pressure, caused by joint subluxation, stress induced bysports, acute and/or repetitive trauma, or poor posture, being placed on thevertebrae and the discs between them.
In Ayurveda it can be correlated withManyagraha as mention by Charak in Shirorogas. As Vata Dosha is mainly responsiblefor Manyagraha , it’s Treatment should plan according to it.
This is Project entitled “RandomizedControl Trial on Erandamula Ghanavati With Nasya in ManyagrahaWith Special Reference to Cervical Spondylosisâ€
All the Parameters of assessment will be based on signs and symptoms ofManyagraha, Oswestry Neck Disability Index and Range of movement of neck.
Patients fulfilling the inclusive criteria will be selectedand Randomisation done by computational Random Number Generator. Allthese patients will be divided into two groups called as Trial Group andControl Group by lottery method followed by filling of consent form in languagebest understood by them. All the Parameters will be assessed before and aftertreatment based on the specially prepared profarma. Apprppriate test will beapllied to the data outcome and discussion and conclusion will be madeaccordingly.
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
- •Patients having sign and symptoms of Manyagraha according to classics.
- •Radiological changes, degenerative changes in cervical spine.
- •The Oswestry neck disability questionnaire, which has been described in criteria of assessment will be taken in to account.
- •Patient willing and able to participate in the study.
- •Neck pain more than three month.
排除标准
- •History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded.
- •The patient who had fix joint or having developed contracture not be included in study.
- •Patient who are not fit for Nasya.
- •Patient with uncontrolled hypertension (≥160/100mm of Hg) and uncontrolled diabetes (Blood sugar level fasting >150mg/dl and post prandial >250mg/dl) will be ruled out.
- •Patient with evidence of malignancy.
- •Patient on prolonged (≥6weeks) medication with corticosteroids, nonsteroidal anti-inflammatory drug, antidepressants, anticholinergic etc.
- •or any drugs that may influence on the outcome of the study.
- •Patient who have a past history of any other systemic disorders will be excluded.
- •Pregnant / lactating women.
- •Patients who had participated in any other clinical trial since last six months.
结局指标
主要结局
1)To study effect of oral administration of Erandamula Ghanavati with Anu Taila Nasya particularly on Oswestry Neck Disability Questionnaire and to compare it’s effect with the effect of oral administration of Panchatiktaghrita Guggulu with Anu Tail Nasya.
时间窗: 1)On zero day assessments i.e. B.T. value. | 2)For trial Group Panchatiktaghrita Guggulu with Anutail Nasya and for Control Group Erandamula Ghanavati with Anutail Nasya will be given for 21 days | 3)Followed up and assessment done on 7th, 14th, 21st day. | 4)Final assessment will be done on 28th day
次要结局
- 1. To study of Manyagraha with reference to Cervical Spondylosis.(2. To study Cervical Spondylosis from modern point of view.)