“Randomized open controlled clinical study to evaluate the efficiency of ‘Trilawan Pashugandhadi Churna’ orally and ‘Lakshadi Tailam’ locally in the management of Katigraha w.s.r.to Lumber Spondylosis in the age group of 35 to 70 yearsâ€
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- In present clinical trial the patient will be assessed based on the signs and symptoms
研究概览
简要总结
Lumbar Spondylosis may be correlated with Katigraha on the basis of clinical
features of the disease. Katigraha as an independent disease entity for the first time was
described in Gadnigraha in Vatavyadhi chapter³ with the same description made
available in Bhavprakash². Vata Dosha with or without Ama dosha settles in Kati and
causes pain and stiffness in the Katipradrsh (Lumbar Spondylosis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Age group 35- 70 years irrespective of caste religion socio-economic and educational status 2 The Roland and Morris disability questionnaire if RDQ score more than 5 3 Radiological degenerative changes in Lumbar Spine 4 Patient having sign and symptoms of Katigraha according to classics 5 Patient willing and able to participate in the study 6 Chronic low back pain more than three months.
排除标准
- •1 History of any fracture of vertebral joints and surgical and diagnostic intervention with reference to affected joints will be excluded Gross disability in performing daily normal routine i.e. bedridden patient or confined to a wheelchair will be excluded.
- •3 Patient with co-morbidities such as gouty arthritis, rheumatoid arthritis or psoriatic arthritis and tubular arthritis 4 Patient with any deformity of Hip or back altering the gait and posture of the patient, ankylosing spondylitis, pelvic i inflammatory disorder 5 Severe alcoholic patient.
- •6 age group below 35 yrs and above 70 yrs 7 Degenerative disc disease may lead to spinal stenosis (narrowing of the spinal canal), vertebral instability.
结局指标
主要结局
In present clinical trial the patient will be assessed based on the signs and symptoms
时间窗: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days
mentioned described in the Ayurveda texts
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(A) SUBJECTIVE CRITERIA
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The parameters will be noted down before and after treatment
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1 Katishul (Lumbar region)
时间窗: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days
2 Aakunchan Prasaran Shula (Pain on flexion and extension)
时间窗: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days
3 Graha (Stiffness)
时间窗: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days
4 Pindanashtava (Tenderness)
时间窗: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days
5 Anidra
时间窗: 0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days
次要结局
- OBJECTIVE CRITERIA(1 Roland & Morris Disability Questionnaire)
研究者
DrUddhav Madhukar Gawali
Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal
