A prospective open labelled single arm non- randomized single centric phase II clinical trial on Komoothira Silasathu Chooranam in the management of Thandagavatham (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
- The outcome will be aimed at reducing the symptoms of Thandagavatham(Lumbar sponsylosis)and to determine the therapeutic efficacy of clinical trials drug(komoothira silasathu chooranam)
研究概览
简要总结
This is a A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF KOMOOTHIRA SILASATHU CHOORANAM IN THE MANAGEMENT OFTHANDAGAVATHAM (LUMBAR SPONDYLOSIS).After purification of the trial drug KOMOOTHIRA SILASATHU, chooranam is prepared and administered at the dosage of 130mgs with the adjuvant Elathy kudineer for 48 days,which is given to 40 known lumbar spondylosis patient( 20 OP and 20 IP patients). The primary outcome will be to determine the therapeutic efficacy of KOMOOTHIRA SILASATHU CHOORANAM in the management of Thandagavatham (lumbar spondylosis ).The secondary outcome will be to collect various Siddha literatures on THANDAGAVATHAM, ,to perform physicochemical, phytochemical, bio chemical analysis of KOMOOTHIRA SILASATHU CHOORANAM ,to evaluate safety profile for acute and sub-acute toxicity of KOMOOTHIRA SILASATHU CHOORANAM,to evaluate pharmacological activities of KOMOOTHIRA SILASATHU CHOORANAM,to study about the prevalence of THANDAGAVATHAM in relation with diet and lifestyle,to evaluate Siddha parameters (including Envagaithervu, Neerkuri-Neikuri) changes and dhegi of THANDAGAVATHAM patients during trial period,to evaluate modern parametric changes in THANDAGAVATHAM,to assess the quality of life of THANDAGAVATHAM patients and to document Bio statistical analysis.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Pain and stiffness in the lumbar region 2.Patient presenting with or without radiating pain to lower limb 3.Difficulty in range of motion 4.Patient who are willing to participate in the study.
排除标准
- •1.Osteoarthritis of hip 2.Patient undergone spinal surgery 3.TB-Spine 4.SLE 5.Infection 6.Rheumatoid arthritis 7.Fracture of spine 8.Chronic renal and liver disease patients 9.Pregnancy and lactating mother.
结局指标
主要结局
The outcome will be aimed at reducing the symptoms of Thandagavatham(Lumbar sponsylosis)and to determine the therapeutic efficacy of clinical trials drug(komoothira silasathu chooranam)
时间窗: 48 days
次要结局
- 1.To collect various aspects of Thandagavatham in Siddha literatures.(2.To evaluate physico chemical,phyto chemical and bio chemical characters of Komoothira Silasathu chooranam.)
研究者
V SAKTHIPRIYA
Government Siddha Medical College and Hospital, Palayamkottai