Clinical study to evaluate the add on effectiveness of Chandrashura granules as food supplement in the management of low back pain
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1.Straight leg raising test positive
研究概览
简要总结
Low back pain has the highest prevalence among musculoskeletal conditions and is the leading cause of disability. Globally, low back pain affects more than 540 million people. In India, nearly 60% of the population has suffered from low back pain at some point of time in their lifespan. Along with Conservative treatment dietary supplements should be advised. Ayurveda termed Ahara as Mahabhaishajya. In this study Chandrashura is selected as it is having Vata-kaphahara and Balapushtivardhana properties and was used in traditional medicine as pain reliever. Keeping time constraint and palatability in mind an attempt is made to transform Chandrashura beeja into granular form which is ready to use as well as tasty.
A minimum of 48 subjects reporting to SDM Hassan who are diagnosed with low back pain and fulfilling inclusion criteria will be recruited and will be alternatively allocated into two groups.
control group : A minimum of 24 subjects will be administered with Trayodashangaguggulu 2-2-2 (b/f) for 30 days with lukewarm water and will be observed for changes. Data will be collected before and after the study.
study group : A minimum of 24 subjects will be administered with Trayodashangaguggulu DS 2-2-2 (b/f) for 30 days with lukewarm water + Chandrashura granules 12gm-0-12gm with milk (b/f) and will be observed for changes . Data will be collected before and after the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
入选标准
- •1.Subjects fulfilling at least one of the diagnostic criteria 2.Gender: All 3.Ready to sign informed consent.
排除标准
- •1.History of spinal surgeries.
- •2.History of spinal injuries 3.Pregnant women 4.Lactating women 5.Known case of kidney stone 6.Known case of pelvic inflammatory disease 7.Known case of malignant disease 8.Known case of spinal tuberculosis 9.Known case of Diabetes mellitus 10.Known case of cauda equina syndrome 11.Those who are undergoing panchakarma procedures.
结局指标
主要结局
1.Straight leg raising test positive
时间窗: 30 days
2.Femoral nerve stretch test positive
时间窗: 30 days
3.Coin test positive
时间窗: 30 days
4.Schober’s test positive
时间窗: 30 days
次要结局
- 1) Visual Analogue Scale(2) Oswestry Disability Index)
研究者
Dr Rachana Yadavaraya
Sri Dharmasthala Manunatheshwara College of Ayurveada and Hospital Hassan