Evaluating the Effect of Integrated Approach Along with Ayurvedic Formulation (Peedanil Gold) in Chronic Low Back Pain: Prospective, Open Label, Single Arm, Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Changes in the severity of pain by using Visual Analogue Scale and disability level of back pain by using The Oswestry Disability Index.
研究概览
简要总结
This is a prospective, open-label, single-arm, observational study. Subjects will be screened on the basis of Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. After enrollment, the investigator will plan 7 days Panchkarma procedure, yoga and naturopathy treatment along with oral medication Peedanil Gold. After 7 days the subject will be continue Peedanil Gold oral medication for next 3 months and the severity of pain and quality of life will be assessed by using specfic questionnaire at Day 30, Day 60 and Day 90 interval..
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who had been experiencing chronic back pain that had been pre diagnosed for longer than three months.
- •Patients with acute musculoskeletal spasm with low back pain due to Lumbar spondylosis osteoarthritis Acute lumbosacral strain Blunt superficial trauma prolapsed intervertebral disc.
- •Patients who are ready to give written informed consent and comply with the protocol requirements.
排除标准
- •Previous back surgery Diabetic and diagnosed with CLBP as a result of organic spine diseases, such as primary or secondary cancer chronic infections as identified by lumbar spine X rays chronic diseases like tuberculosis renal disease hemorrhagic sickness inflammatory low back pain and acute rheumatoid arthritis were not included in this study.
- •Patients with acute muscle spasms who need parenteral therapy surgery or hospital admissions for management.
- •Pregnant or lactating women.
- •Patients are unwilling or unable to comply with the study procedures.
结局指标
主要结局
Changes in the severity of pain by using Visual Analogue Scale and disability level of back pain by using The Oswestry Disability Index.
时间窗: From Baseline to Day 7 Day 30 Day 60 and Day 90
次要结局
- Changes in the Quality of life by using WHOQOL-BREF(From Baseline to Day 7 Day 30 Day 60 and Day 90)
研究者
Dr Ajay Singh
Patanjali Ayurveda Hospital