AN OPEN NON RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF “INJI CHOORANAM (INTERNAL)â€AND VATHA KESARI THAILAM (EXTERNAL) IN THE MANAGEMENT OF THANDAGA VATHAM ( LUMBAR SPONDYLOSIS)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Improvement of Aberdeen low back pain scale scoring before and after treatment.
研究概览
简要总结
BACKGROUND : This is an open clinical trial that evaluates the effectiveness of Siddha herbal formulation INJI CHOORANAM(INTERNAL) and VATHA KESARI THAILAM (EXTERNAL) in the management of THANDAGA VATHAM (LUMBAR SPONDYLOSIS) patients through Aberdeen low back pain scale and MRI Lumbar Spinebefore and after treatment. Lumbar spondylosis also termed as lumbar osteoarthritis, discdegeneration, degenerative disc disease. It is found very commonly in those used to heavy work. The degenerative changes are simply a manifestation of increasing age or wear and tear. Low back pain (LBP) affects approximately 60–85% of adults during some point in their lives. 85.5% of individuals aged 45–64 years demonstrate osteophytes within the lumbar spine. Degenerative changes may appear in young individuals without no trauma history.
OBJECTIVE : To estimate the therapeutic efficacy of siddha herbal formulation INJI CHOORANAM ( INTERNAL ) and VATHA KESARI THAILAM ( EXTERNAL ) in the management of THANDAGA VATHAM ( LUMBAR SPONDYLOSIS ) patients through Aberdeen low back pain scale before and after treatment.
METHODOLOGY : A Total of 10 diagnosed patients of Thandaga vatham (Lumbar spondylosis) within the age limit of 30 -60 years willing to participate in the study ,by signing the consent form will be enrolled in the study. Pregnancy and lactation, Known cases of Cardiac disease, Auto immune disease like Rheumatoid arthritis, SLE, Psoriasis, Mixed connective tissue disorders.Spina bifida, Osteomyelitis, Tuberculosis in spine, Renal diseases, Other systemic illness will be excluded. Assessment in improvement is done through Aberdeen low back pain scale and MRI Lumbar Spine before and after treatment.
RESULTS AND DISCUSSION : The result will be statistically analyzed.
KEY WORDS : Thandaga vatham, Lumbar spondylosis, Inji chooranam, Vatha kesari thailam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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 who are having symptoms of Lower back pain, Excessive sweating, Reduced range of movements, Body tiredness 2.Patient who are willing to sign informed consent form
- •Patients who are willing to give radiological investigation.
排除标准
- •Known case of, 1.Cardiac disease 2.Auto immune disease like Rheumatoid arthritis, SLE,Psoriasis,Mixed connective tissue disorders.
- •3.Spina bifida 4.Osteomyelitis 5.Tuberculosis in spine 6.Pregnancy and lactation 7.Renal diseases 8.Other systemic illness.
结局指标
主要结局
Improvement of Aberdeen low back pain scale scoring before and after treatment.
时间窗: 2 MONTHS- SCREENING | 2 MONTHS- DATA COLLECTION | 2 MONTHS- DATA ANALYSIS AND OUTCOME
Comparing the reduction of clinical symptoms before and after treatment
时间窗: 2 MONTHS- SCREENING | 2 MONTHS- DATA COLLECTION | 2 MONTHS- DATA ANALYSIS AND OUTCOME
次要结局
未报告次要终点