A PROSPECTIVE OPEN LABELLED NON RANDOMIZED PHASE II CLINICAL TRIAL ON NOCHI VER KUDINEER IN THE MANAGEMENT OF THANDAGAVADHAM(LUMBAR 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
- Moderate improvement - score 10-20%
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 NOCHI VER KUDUNEER in the management of THANDAGAVADHAM (LUMBAR SPONDYLOSIS).The trial drug will be administered at the dose of 30-60ml/ twice a day(orally) 45 days in 40 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 evaluation of therapeutic efficacy of the trial drug NOCHI VER KUDINEER. The secondary outcome will be the evaluations 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 events (AE) is noticed and 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
- 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.Patient presenting with pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggregating on forward and backward bending 2.SLR test positive patients 3.Patient complaining of back pain functional scale score should be range from below 30 4.Willing to participate in the clinical trial 5.Patient confirmed radiological diagnosis in Lumbar spondylosis.
排除标准
- •1.Age below 30 and above 60 2.Tuberculosis of spine 3.SLE 4.Chronic kidney disease 5.Fracture of spine 6.Congenital spinovertebral deformities 7.Mixed connective disease 8.Pregnancy 9.Lactating mother 10.Chronic Liver disease.
结局指标
主要结局
Moderate improvement - score 10-20%
时间窗: 45 days
1.Reduction of the symptoms of the pain in lumbar and lowwr limbs 2.Improvement of the range of movements in the lumbar and lower limbs 3.The outcome is aimed at reducing the pain and the range of the movements
时间窗: 45 days
No improvements score 40%
时间窗: 45 days
Good improvement - score 10% or below 10%
时间窗: 45 days
Mild improvement - score 20-30%
时间窗: 45 days
次要结局
- 1.To evaluate the physicochemical, phytochemical bio chrmical analysis of clinical trial drug(2.To evaluate the safety profile for acute and subacute toxicity of the trial drug.)