Efficacy and Safety of BBETTER OrthoUrja in Knee and Joint Pain Management: 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
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of BBETTER OrthoUrja in adults with mild to moderate knee and joint pain or osteoarthritis. The study will be conducted as a randomized double blind placebo controlled clinical trial. Eligible participants aged 30 to 70 years will be randomly assigned to receive either BBETTER OrthoUrja capsules or placebo capsules twice daily for a period of eight weeks.
The primary objective of the study is to assess the effect of BBETTER OrthoUrja on knee and joint pain as measured by the Visual Analog Scale. Secondary objectives include evaluation of physical function mobility quality of life and overall joint health using validated assessment tools such as WOMAC KOOS TUG NPRS and SF 12. Safety will be assessed through monitoring of adverse events vital signs and laboratory parameters including inflammatory and cartilage related biomarkers.
The hypothesis of this study is that BBETTER OrthoUrja will significantly reduce knee and joint pain 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
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged 30 to 70 years.
- •Mild to moderate knee/joint pain (VAS score 3 to 7).
- •Diagnosis of mild to moderate osteoarthritis (Kellgren-Lawrence Grade 1 to 3).
- •Pain duration of at least 3 months.
- •BMI between 18.5 and 30 kg/m².
- •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
研究者
Dr Sanjeev Kumar Kare
Government Medical College & Govt. General Hospital