A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a combination of oral and topical Unani Formulations in the Management of Waja‘ al-MafÄsÌ£il (Osteoarthritis Knee)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Reduction in Pain by Using VAS
研究概览
简要总结
osteoarthritis also known as degenerative joint disease is the most common form of chronic disorders of synovial joints. In India, Knee osteoarthritis affects 28.7% population especially, females (31.6%). OA of Knee is the major healthcare issues in an ever ageing population . confers major disability and compromised quality of life. in Unani System Of Medicine the great unani physicians detailed description in his treatise regarding the disease under the term Waja’al-Mafasil. Current pharmacological treatment are often ineffective or come with risky side effects like those from NSAIDs. There is urgent need to explore safe and effective herbal formulatons.in this regard, this Randomized ,Open Label, Active Control study is designed to evaluate the safety and efficacy of Safuf and Roghan Gul e Aak in the management of waja’al-Mafasil (osteoarthritis Knee).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of any sex aged between 40to 65years 2.Clinical and Radiographic Knee Osteoarthritis as per the following American College of Rheumatology (ACR) criteria: a.
- •Knee Pain b.
- •Osteophytes on Knee Radiograph, and c.
- •At least 1 of the following 3 criteria: i.
- •Age ≥40 years ii.
- •Morning Stiffness lasting ≤30 minutes iii.
- •Crepitus on Active Knee Motion 3.Knee OA of Kellgren-Lawrence Grade 1 to 3 4.Participants who are able and willing to comply with the protocol and to sign IEC approved ICF.
排除标准
- •1.Knee OA of Kellgren-Lawrence grade IV
- •Secondary OA, Inflammatory joint diseases (e.g. RA, psoriatic arthritis, gout), or any other type of arthritis 3.Patients on long-term steroid treatment 4.H/o having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month 5.Pregnant or Lactating Women 6.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction 7.Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies.
结局指标
主要结局
1.Reduction in Pain by Using VAS
时间窗: 42 Days
2.Reduction in WOMAC Scores from baseline
时间窗: 42 Days
次要结局
- 1.Joint Tenderness On a 4 Point Likert Scale(2.50 Foot Walk Test)
研究者
Atiya Begum
National Research Institute of Unani Medicine for Skin Disorders