Effect of homoeopathic medicine Calcarea flourica in the treatment of Lumbar spondylosis among adults : a prospective single-arm clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Changes can be seen on Visual Analog Scale VAS
研究概览
简要总结
This prospective single-arm clinical study aims to evaluate the effect of Homoeopathic medicine Calcarea Fluorica in the centesimal potency in the cases of lumbar spondylosis among adults, focusing on clinical outcomes such as pain relief and improvement in mobility. Primary outcome is to assess the changes in visual analogue scale (VAS) . VAS will be used at baseline, at 3rd month and at 6th month for analysis. The result will be concluded accordingly. Study duration is 15 months. Sample size will be 42.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 30 years to 59 years.
- •Confirmed diagnosis of lumbar spondylosis based on clinical evaluation and imaging studies Symptoms such as lower back pain and stiffness present.
- •Participants who provide informed consent to participate in the study.
排除标准
- •Individuals who have undergone recent surgery on the lumbar spine or adjacent areas within the last six months.
- •Participants who has scoliosis Participants with severe systemic illness (e.g. malignancies, uncontrolled diabetes, severe cardiovascular diseases).
- •Pregnant or lactating women.
- •Participants deemed at high risk for non-compliance with the study protocol, including those with substance abuse issues or psychiatric disorders.
结局指标
主要结局
Changes can be seen on Visual Analog Scale VAS
时间窗: 15 months | Enrollment period for 6 Months | Follow Up every month for 6 Months | Study & Data Analysis for 3 months | First dose will be given after case taking | Subsequent doses according to the follow ups for a period of 6 months | VAS scale will be used as baseline at 3rd months and at 6th months
Changes can be positive or negative or no change
时间窗: 15 months | Enrollment period for 6 Months | Follow Up every month for 6 Months | Study & Data Analysis for 3 months | First dose will be given after case taking | Subsequent doses according to the follow ups for a period of 6 months | VAS scale will be used as baseline at 3rd months and at 6th months
次要结局
未报告次要终点
研究者
Dr Ayushi Gaur
Bakson Homoeopathic medical college and hospital