A prospective open labelled, single arm, non-randomized, single centric, phase II clinic trail to determine the effectiveness of kanduparangi chooranam in the management of ceganavatham (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. The outcome is aimed at reducing pain and increasing range of movement.
研究概览
简要总结
The study is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRAIL TO DETERMINE THE EFFECTIVENESS OF KANDUPARANGI CHOORANAM IN THE MANAGEMENT OF CEGANAVATHAM (CERVICAL SPONDYLOSIS). The trial drug will be administered at the dose of 3gms twice a day orally with hot water for 45 days on 40 (20 OP + 20 IP) patients. 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 determining the clinical effectiveness of KANDUPARANGI CHOORANAM on CEGANAVATHAM (CERVICAL SPONDYLOSIS). The secondary outcome will be evaluating the siddha diagnostic parameters, assessment of pharmacological and biochemical parameters of trial drug. Incase of any Adverse Events (AE) noticed, 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
- Na
- 盲法
- None
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 ro upper limb without numbness, giddiness and neck stiffness
- •Restricted neck movements
- •Willing for doing laboratory investigations and X-Ray imaging
- •The neck disability index score should be equal or greater than 40%.
排除标准
- •Age: Below 20 years and above 60 years
- •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
1. The outcome is aimed at reducing pain and increasing range of movement.
时间窗: 45 days
2. Reduction of OSWESTRY DISABILITY INDEX score to 10 points on comparison with OSWESTRY DISABILITY INDEX score prior to the treatment.
时间窗: 45 days
次要结局
- To evaluate physicochemical, phytochemicals, biochemical analysis of clinical trial drug(To evaluate the safety profile for acute and subacute toxicity of the trial drug)
研究者
Dr K ROHINI
Government siddha medical College, Palayamkottai.