A PROSPECTIVE OPEN LABELLED SINGLE ARM NON RANDOMIZED SINGLE CENTRIC PHASE II CLINICAL TRIAL ON CHITRAMANAKKU ILAI CHOORANAM IN THE MANAGEMENTOF CEGANAVATHAM(CERVICAL SPONDYLOSIS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of the symptoms of pain in neck and upper limbs
研究概览
简要总结
The study is a prospective open labelled single arm non randomized single centric phase II non randomized clinical study to evaluate the therapeutic efficacy of CHITRAMANAKKU ILAI CHOORANAM in the management of CEGANAVATHAM(CERVICAL SPONDYLOSIS).The trial drug will be administered at the dose of 2mg/twice a day(orally)45 days in 40patients.The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital,palayamkottai,Tirunelveli,Tamilnadu.The primary outcome will be the evaluations of siddha diagnostic parameters,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. Furthur 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
- 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 neck movements.
- •3.Willing for doing laboratory investigations and X-Ray imaging.
- •4.The neck disability Index score should be equal or greater than 40%.
排除标准
- •1.Age : Below 20 Years, Above 60 years 2.Traumatic injury 3.Systemic hypertension 4.Ischemic heart diseases 5.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
Reduction of the symptoms of pain in neck and upper limbs
时间窗: 45 days
Improvement of the range of movements in the neck and upper limb
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-score10%below10%
时间窗: 45 days
Moderate improvement-score10-20%
时间窗: 45 days
Mild improvement-score20-30%
时间窗: 45 days
No improvement-score40%
时间窗: 45 days
次要结局
- To evaluate the physicochemical,phytochemicals,biochemical analysis of clinical trial drug(To evaluate the safety profile for acute and subacute toxicity of the trial drug)