An Open labelled double arm non-randomised phase II clinical trial to compare the efficacy of VARMA MANIPULATION with KARUNKURINJI KUDINEER (INTERNAL)and ETTI PATTAI ENNAI (EXTERNAL) in the treatment of KOARAI VATHAM
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
- Assessment of change from baseline in QUEBEC BACK PAIN DISABILITY SCALE at day of between Group I and Group II for varma manipulation and internal and external medicine
研究概览
简要总结
LUMBAR SPONDYLOSIS is the term given to theoccurrence of degenerative disc disease and osteoarthritic change in the lumbarspine. Within the literature, lumbar spondylosis encompasses numerous associated pathologiesincluding spinal stenosis, degenerative spondylolisthesis, osteoarthritis andmany others.spondylosis is not aclinical diagnosis but instead a descriptiveterm utilized to designate spinal problems. Thelumbar spine carries most of the body’s weight. therefore degenerative changesaffect its structure causes pain with activity such as walking and standing,lifting objects or after a long period of rest. The manipulation of varma pointsfor treating diseases is called varma therapy. According to varma textthe signs and symptoms of koarai vatham mentioned in vatha noi nithanamcan be correlated with lumbarspondylosis (Ref. Vaadha Noi Nidhanam – 800(42/800). This study is to evaluate the therapeutic efficacy of VarmaManipulation and clinical efficacy of karunkurinji kudineer (Internal) and ulunthennai (External).on koaraivatham (lumbar spondylosis). The manipulation of varma pointsfor treating diseases is called varma therapy. According to varma textthe signs and symptoms of koarai vatham mentioned in vatha noi nithanamcan be correlated with lumbarspondylosis (Ref. Vaadha Noi Nidhanam – 800(42/800). This study is to evaluate the therapeutic efficacy of VarmaManipulation and clinical efficacy of karunkurinji kudineer (Internal) and ulunthennai (External).on koaraivatham (lumbar spondylosis).
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
- •Patients having symptoms of Pain in the lumbar region, Radiating pain to buttocks and lower limbs ,stiffness present in lumbar region, Exacerbation of pain on movements, Pain increased on forward bending, Tingling sensation.(Numbness) Patients who are willing to give radiological investigation and provide blood for lab investigation.
- •Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can option out of the trial of his/her own conscious discretion.
排除标准
- •Auto immune diseases like Rheumatoid arthiritis, SLE, Psoriasis, Mixed connective tissue disorder.
- •Spina bifida Pregnancy and lactation Osteo myelitis Renal Disease Tuberculosis in spine Patient with any other serious illness.
结局指标
主要结局
Assessment of change from baseline in QUEBEC BACK PAIN DISABILITY SCALE at day of between Group I and Group II for varma manipulation and internal and external medicine
时间窗: Group I Intermittent varma manipulation within 48 days | 1st sitting 50 percentage of symptoms will reduce | 2nd sitting 80 percentage of symptoms will reduce | Group II After giving internal and external medine for 12 days with varma manipulation 50 percentage of primary symptoms will reduce | within 48 days 80 percentage of symptoms will reduce
次要结局
- Assessment of OSWESTRY LOWBACK PAIN DISABILITY QUESTIONNAIRE.(Assessment of safety parameters)