Efficacy and Safety of BBETTER SpineUrja in Managing Lower Back Pain and Sciatica: A Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in knee pain intensity using the Visual Analog Scale (VAS) from baseline.
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of BBETTER SpineUrja in adults with mild to moderate lower back pain and sciatica. The study will be conducted as a randomized double blind placebo controlled clinical trial. Eligible participants aged 30 to 65 years will be randomly assigned to receive either BBETTER SpineUrja capsules or placebo capsules twice daily for a duration of eight weeks.
The primary objective of the study is to assess the effect of BBETTER SpineUrja on pain intensity using the Visual Analog Scale. Secondary objectives include evaluation of functional disability spinal mobility and quality of life using validated tools such as the Oswestry Disability Index Roland Morris Disability Questionnaire and Short Form 12. Safety will be assessed through monitoring of adverse events vital signs and laboratory investigations including inflammatory biomarkers and liver and kidney function parameters.
The hypothesis of this study is that BBETTER SpineUrja will significantly reduce lower back pain and sciatica symptoms improve functional outcomes and enhance quality of life compared to placebo while being safe and well tolerated.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 盲法
- 双盲
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- Adults aged 30 to 65 years.
- Chronic lower back pain or sciatica for at least 3 months.
- Pain intensity score between 4 and 7 on the Visual Analog Scale (VAS).
- Willingness to adhere to study guidelines and avoid additional spine-related medications or treatments.
- Ambulatory and capable of performing basic physical activities.
- Willingness to discontinue other joint health supplements or anti-inflammatory medications (except rescue acetaminophen).
排除标准
- 未提供
结局指标
主要结局
Change in knee pain intensity using the Visual Analog Scale (VAS) from baseline.
时间窗: Baseline, Week 4, Week 8
次要结局
- Change in spinal mobility and function improvement using Oswestry Disability Index (ODI) scores from baseline.(Baseline, Week 4, Week 8)
- Change in spinal mobility and function improvement using Roland-Morris Disability Questionnaire (RMD) scores from baseline.(Baseline, Week 4, Week 8)
- Change in Short Form-12 (SF-12) for Quality of Life score from baseline.(Baseline, Week 4, Week 8)
- Change in Systemic Inflammatory Biomarkers (IL-6, CRP) from baseline.(Baseline, Week 8)
- Change in laboratory values for liver parameters (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) from baseline.(Baseline, Week 8)
- Change in laboratory values for kidney parameters (serum creatinine, blood urea nitrogen) from baseline.(Baseline, Week 8)
- Change in Treatment-Emergent Adverse Events (TEAEs) from baseline.(Baseline, Week 4, Week 8)
- Change in Treatment-Emergent Serious Adverse Events (TESAE) from baseline.(Baseline, Week 4, Week 8)
研究者
Dr Sanjeev Kumar Kare
Government Medical College & Govt. General Hospital
研究点 (1)
标识符
- CTRI 编号
- CTRI/2026/01/100851
- 其他研究编号
- BBETTER/Spine/Urja/25/03, Version 1.0; dt. 25th Feb 2025
日期
- 最近更新
- (8个月前)
