A Prospective Open labelled, Non-randomized Phase II clinical trial of SANGAN ILAI KUDINEER in the management 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
- 60
- 试验地点
- 1
- 主要终点
- 2.Improvement of the range of movements in the 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 SANGAN ILAI KUDINEER in the management if Cegana vatham( Cervical spondylosis). The trial drug will be administered at the dose of 100 ml BD A/F for 45 days in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu . The Primary outcome will be the evaluation of therapeutic efficacy of trial drug SANGAN ILAI KUDINEER. The secondary outcome will be the evaluation of Siddha diagnostic parameters, assessment of safety profile of trial drug,assessment of pharamocological and biochemical parameters of trail drug.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Neck pain radiating to upper limb with or without numbness, giddiness and neck stiffness.
- •2.Restriction of neck movements.
- •3.Willing for doing X-ray imaging.
- •4.Neck disability index score should be equal or greater than 40%.
排除标准
- •1.Traumatic injury 2.systemic hypertension
- •Diabetes Mellitus
- •Ischemic heart disease
- •chronic kidney disease 6.Tuberculosis in spine 7.Secondary malignancy 8.Chronic systemic illness 9.Congenital spinal anomalies.
结局指标
主要结局
2.Improvement of the range of movements in the neck and upper limbs
时间窗: 45 days
1.Reduction of pain in neck and upper limbs
时间窗: 45 days
次要结局
- 1.Evaluation of pharmacological, biochemical and phytochemical analysis of trial drug(2. Determination of safety profile of trial drug)