A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a Unani Formulation in the Management of Waja‘ al-MafÄá¹£il (Osteoarthritis)
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. The decrease in severity of pain, stiffness and limitation of function of affected knee will be assessed by WOMAC OA Index.
研究概览
简要总结
Osteoarthritis (OA) is the most common chronic joint disease with a prevalence of 22-39% in India. NSAIDs (Non-steroidal Anti-inflammatory Drugs) are widely used in the symptomatic management of OA. But, NSAIDs cannot be used for a long period because they have so many adverse effects such as bleeding, gastrointestinal ulcer, etc. There are so many Unani formulations, which have been used in the treatment of Waja‘al-MafÄá¹£il (Osteoarthritis) by Unani Physicians since ages, one of them is this Classical Unani Formulation containing several herbs in the form of Majun to be made with Honey, which has been selected for a clinical study to evaluate its safety and efficacy on modern scientific parameters in the Management of Waja‘ al-MafÄá¹£il (Osteoarthritis). Participants fulfilling the inclusion and exclusion criteria will receive either test or control drug as per randomization, in test drug participants will receive classical unani formulation in the form of Majun (electuary) 5gm to be taken orally twice a day after meals. In control drug participants will be given 1 Celecoxib capsule (100mg) to be taken orally twice a day after meals. various parameters like WOMAC OA Index, Visual Analogue Scale, Likert Scale, 50-Foot Walk Test will be used to evaluate the efficacy and various laboratory investigations will be done to evaluate the safety of the test drug. Duration of the study is 6 weeks. Statistical Analysis: Chi-square test and “student-t test†will be used to evaluate the significance of results. For intra-group comparison, ‘paired t-test’ and for inter-group comparison ‘unpaired t-test’ will be applied. The p-value of <0.05 will be considered as the level of statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of any gender aged 50-65 years
- •Clinical and Radiographic Knee Osteoarthritis as per the following ACR criteria: (a)Knee Pain (b)Osteophytes on Knee Radiograph, and (c)At least 1 of the following 3 criteria: i.
- •Age ≥50 years ii.
- •Morning Stiffness lasting ≤30 minutes iii.
- •Crepitus on Active Knee Motion
- •Body Mass Index (BMI): <40 Kg/m2.
排除标准
- •Age less than 50 years and more than 65 years
- •Knee OA of Kellgren-Lawrence grade IV
- •BMI more or equal to 40
- •Patients with Knee Joint Effusion
- •Secondary OA, Inflammatory joint diseases (e.g., RA, ankylosing spondylitis, psoriatic arthritis, gout), or any other type of arthritis
- •Patients on long-term steroid treatment
- •History of having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month
- •Any significant systemic diseases (hepatic, renal gastrointestinal, cardiovascular, neurologic or psychiatric disorder) and Diabetes Mellitus
- •History of Peptic Ulcer Disease & Bleeding Disorders
- •Known hypersensitivity to study drug or any of its ingredients
- •Pregnant and lactating women
- •History of addiction (alcohol, drugs)
- •Patients considered not eligible in the Investigator’s opinion.
结局指标
主要结局
1. The decrease in severity of pain, stiffness and limitation of function of affected knee will be assessed by WOMAC OA Index.
时间窗: 6 Weeks
2. The decrease in the severity of pain in affected knee will be assessed by 0-100 mm Visual Analog Scale (VAS)
时间窗: 6 Weeks
3. Joint tenderness (pain on palpation) will be graded on a 4-Point Likert Scale (0-3) based on the patient’s response to palpation over the affected joint.
时间窗: 6 Weeks
4. Patient’s Global Assessment of Response to Therapy (PGA) on a 5- point Likert Scale (0-4)
时间窗: 6 Weeks
5. Investigator’s Global Assessment of Response to Therapy (IGA) on a 5-point Likert Scale (0-4)
时间窗: 6 Weeks
6. 50-Foot Walk Test (50-FWT) will also be used to study physical performance.
时间窗: 6 Weeks
次要结局
- Systemic safety assessment(6 Weeks)