A Prospective open labelled non randomized phase II clinical study on pavattai ilai kutinir in the management of Tantaka Vatam (lumbar spodylosis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- If during treatment or after treatment reduction of the following symptoms
研究概览
简要总结
A study is a prospective open labelled phase II non randomized clinical study to evaluvate the therapeutic efficacy of pavattai ilai kudineer in the management of Thandaga Vatham ( Lumbar Spondylosis). The trial drug will be administered at the dose of 30 to 50 ml/Twice a day B/F 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 their evaluation of therapeutic efficacy of trial drug pavattai ilai kudineer. The Secondary outcome will be they evoluation 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 event (AE) is notice and it will be referred to pharmacovigilance department of SCRI. Further management of patient 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
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient presenting with pain and stiffness in the Lumbar region,radiating pain to buttocks and lower limbs, pain aggravating on forward and backward bending.
- •Schoper,SLR test positive in Thandaga Vatham.
- •Patient complaining of back pain functional scale score should be range from below
- •Patient willing to participate the clinical trial.
- •Confirmed Radiological diagnosis in Lumbar Spondylosis.
排除标准
- •Tuberculosis of spine 2)SLE 3)Chronic kidney disease 4)Fracture of spine 5)Congenital Spino Vertebral Deformities 6)Mixed connective disease 7)Pregnency 8)Lactating mother 9)Chronic liver disease.
结局指标
主要结局
If during treatment or after treatment reduction of the following symptoms
时间窗: 6 weeks
Pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggravating on forward and backward beding.
时间窗: 6 weeks
次要结局
- Documentation of analgesic activity through SCALE SCORE.(45 days)