Efficacy of Homoeopathic medicines in the management of Sciatica assessed by the Numerical Rating Score -A Randomized Single Blind Placebo Controlled study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Pain of sciatica using Numerical Rating Score
研究概览
简要总结
This study is a randomized single blind placebo controlled trail conducted in the India. Efficacy of Homoeopathic Medicines in the management of Sciatica will be studied. The Primary outcome measures will be pain of sciatica using the Numerical Rating Score the data will be taken at baseline, at three month and six month and will be compared to assess the efficacy of homoeopathic medicine in cases of Sciatica. The secondary outcome measures will be impact of sciatica, on the quality of life using Revised Oswestry Disability Index.Score will be calculated before at baseline, three month and six month after the homoeopathic treatment or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Both genders male and female 2) Patient who suffer from the sciatica more than eight week of duration Diagnosis of sciatica will be done according to ICD 10 diagnostic criteria M 51 54.3
- •4 code for sciatica 3) Sciatica with common causes only as disc herniation stenosis etc confirmed with Magnetic resonance Imaging MRI 4) Pain Score NRS Numerical Rating Score more than 3 5) Age group 20 to 60 year 6) Patients willing to participate in the study and give written informed consent.
排除标准
- •Patient who had undergone surgery of spine region within 1 year 2)Patients who had received trans-foraminal epidural injection in 6 months 3)Patients with diagnosed major psychiatric illness or personality disorders 4)Patient taking other mode of treatment such as allopathic, ayurvedic, herbal, homoeopathic etc.
- •for sciatica.
- •Pregnant women, Lactating women 6)Patient not able to fill the Revised Oswestry Disability Index (ODI) related questionnaire and Numerical Rating Score (NRS).
结局指标
主要结局
Pain of sciatica using Numerical Rating Score
时间窗: Data will be taken at baseline at three month & six month & will be compared to assess the efficacy of homoeopathic medicine in cases of Sciatica
次要结局
- Impact of sciatica on the quality of life using Revised Oswestry Disability Index(Score will be calculated at baseline at three month & six month after the homoeopathic treatment or placebo)