A prospective open labelled non Randomized phaseII clinical trial on VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM(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
- 1.Reduction of the symptoms of painin neck and upper limbs
研究概览
简要总结
The study is a Prospective Open labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM(CERVICAL SPONDYLOSIS). The trial drug will be administered at the dose of 30-60 ml /twice a day (orally) 45 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary out come will be the evaluations of siddha diagnostic parameters, assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Neck pain radiating to upper limb with or without numbness, guiddiness and neck stiffness Restriction neck movememts Willing for doing laboratory investigation and xray imaging The neck diability index score should be equal or greater than 40%.
排除标准
- •Age less than 20 greater than 60 Traumatic injury Systemic hyper tension Ischeamic heart diseases Chronic kidney disease Tuberculosis of spine Secondary maliganancy Chronic systemic illness Congenital spinal anomaly Pregnancy Lactating mother Extra cervical rib.
结局指标
主要结局
1.Reduction of the symptoms of painin neck and upper limbs
时间窗: 45 days
Improvement of the range of movements in the neck and upper limbs
时间窗: 45 days
The outcome is aimed at reducing pain and increasing the range of movements
时间窗: 45 days
Good improvement-score 10%/below10%
时间窗: 45 days
Moderate improvement-score10-20%
时间窗: 45 days
Mild improvement-score 20-30%
时间窗: 45 days
No improvement-score 40%
时间窗: 45 days
次要结局
- To evaluate the physicochemocal, phytochemicals, biochemical analysis of clinical trial drug(To evaluate the safety profile for acute and subacute toxicity of the trial drug)