A Prospective open labelled phase II non randomized clinical trial on mineral drug of Appalakara Chooranam for the treatment of Cegana vatham (Cervical Spondylosis)
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
- The therapeutic efficacy of trial drug Appalakara chooranam on Cegana Vatham
研究概览
简要总结
The Study is A prospective open labelled phase II non randomized clinical trial to evaluate the therapeutic efficacy of mineral drug of Appalakara Chooranam for the treatment of Cegana Vatham 30mg kg BW daily twice time per day with water for 30 days in 40 patients during the trial period of 18 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic efficacy of trial drug Appalakara Chooranam on Cegana Vatham The Secondary outcome will be the evaluation of siddha diagnostic parameters
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Neck pain radiating to upper limb with or without numbness giddiness and neck stiffness Restriction neck movement Willing for doing laboratory investigations and x ray imaging The neck disability index score should be equal or greater then 40 present.
排除标准
- •Traumatic injury Systemic hypertension Ischemic heart diseases Chronic kidney disease Tuberculosis in spine Secondary malignancy Chronic systemic illness Congenital spinal anomalies.
结局指标
主要结局
The therapeutic efficacy of trial drug Appalakara chooranam on Cegana Vatham
时间窗: The therapeutic efficacy of trial drug Appalakara chooranam on Cegana Vatham
次要结局
- Evaluation of Siddha diagnostic parameters(30 days)