A Prospective Openlabelled, Non- randomized,Phase II clinical trial of Marutham Pattai Chooranam in the management of Thandaga Vatham(Lumbar 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
- 1.Reduction in clinical symptoms of Lumbar Spondylosis
研究概览
简要总结
This study is prospective,open labelled,non-randomized phae II clincal study to evaluate the therapeutic efficacy of MARUTHAM PATTAI CHOORANAM in the management of Thandaga vatham (Lumbar Spondylosis).The trial drug will be administered at the dose of 35mg/kg/BW/twice a day orally A/F along with hot water as adjuvant for 45 days in 60 patients(30 in OPD +30in IPD).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 the trial drug Marutham Pattai Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters assessment of safety profile of trial drug, assessment of pharamcological and biochemical parameters of the trial 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.Patients having clinical symtoms of lumbar spondylosis
- •Patients with low back pain with radiograph of lumbosacral spine showing a.loss of natural lumbar lordosis b.Reduction in disc space c.formation of osteophytes d.osteoporosis e.subluxation of vertebra 3.
排除标准
- •1.pregnant women 2.TB of spine 3.Systemic Lupus Erythematosus 4.Congenital scoliosis,kyphosis 5.Patients in treatment for any other system of medicine for the same problem during clinical trials 6.Patients with lumbar spondylosis need in other emergency treatment.
结局指标
主要结局
1.Reduction in clinical symptoms of Lumbar Spondylosis
时间窗: 45 days
次要结局
- 1.Determination of safety profile,Pharmacological and bio chemical parameters of trial drug(2.Evaluation of additional effects and siddha parameters changes in Thandaga Vatham)