A Prospective open labelled single arm non randomized single centric phase II clinical trial on kushtathy 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
- To determine the clinical effectiveness of kushtathy chooranam in the management of Thandagavatham (Lumbar spondylosis)
研究概览
简要总结
This is a PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF KUSHTATHY CHOORANAM IN THE MANAGEMENT OF THANDAGAVATHAM (LUMBAR SPONDYLOSIS).After purification of the trial drug KUSHTATHY CHOORANAM, is prepared and administered at the dosage of 2 grams with the adjuvant Hot water 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 KUSHTATHY 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 KUHTATHY CHOORANAM ,to evaluate safety profile for acute and sub-acute toxicity of KUSHTATHY CHOORANAM ,to evaluate pharmacological activities of KUSHTATHY 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
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.patients presenting with or without radiating pain to lower limb.
- •3.Difficulty in range of motion.
- •4.Patients who are willing to participate in the study.
排除标准
- •1.Age less than 30 years and more than 65 years 2.Osteoarthritis of hip 3.Patient undergone spinal surgery 4.TB-spine 5.SLE 6.SLR test 7.Infection 8.Rheumatoid arthritis 9.Fracture of spine 10.Chronic renal and liver disease Patients 11.Pregnancy.
结局指标
主要结局
To determine the clinical effectiveness of kushtathy chooranam in the management of Thandagavatham (Lumbar spondylosis)
时间窗: 40 days
次要结局
- 1.To collect various Siddha literatures and modern journals for literature review on THANDAGAVATHAM(2.To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status.)