A Single Blind, Randomized, parallel group study to compare efficacy and safety of Unani formulation Qurs-e-Mafasil with Paracetamol in patients with Tahajjur al-Mafasil(Osteoarthritis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • Improvement in clinical sign and symptoms
研究概览
简要总结
This study is designed as a single blindrandomized parallel group trial in patients with Tahajjural-Mafasil(Osteoarthritis). Patients will be enrolled if theysatisfy inclusion and exclusion criteria. The patients enrolled in thestudy will receive the medicine Qurs-e- Mafasil or Tablet Paracetamol as allocated by randomization method. Thetotal duration of treatment will be 8 weeks and the follow-up for all clinicalparameters will be conducted every two weeks. The laboratory tests will beconducted at all follow ups.
Composition ofQurs-e- Mafasil
| S. No. |
Ingredients
Scientific names
Quantity
|1.
Zanjabeel
Zingiber officinale R.
1 part
|2.
Suranjan
Colchicum luteum B.
2 parts
|3.
FilfilSiyah
Piper nigrum L.
1 part
|4.
Asgand
Withaniasomnifera D.
1 part
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects fulfilling ACR clinical criteria for knee OA; andor
- •Subjects having grade II and III Osteoarthritisin knee radiography as perKellegrenLawrence criteria
- •Subjects presenting with/ without the following signs and symptoms: Joint Pain Early morning stiffness Tenderness Swelling Reduced mobility.
排除标准
- •Subjects having Rheumatoid arthritis, Systemic joint disease or any other type of arthritis
- •Obese Subjects having BMI>30
- •Subjects with uncontrolled Hypertension, Diabetes Mellitus, Tuberculosis, Malignancy, Epilepsy and any other disease requiring long-term treatment
- •Known cases of Renal/ hepatic impairment
- •Patient receiving Intra-articular treatment (e.g., Corticosteroid or Hyaluronic acid) or treatment with medicine for O.A. in previous 3 months (e.g., Glucosamine sulphate, Chondroitin sulphate, Diacerine piascledine)
- •Subjects undergone Arthroscopy or any Knee surgery during last 6 months
- •Pregnancy & lactation.
结局指标
主要结局
• Improvement in clinical sign and symptoms
时间窗: 8weeks
• Evaluation of pain by visual analog scale (VAS pain)
时间窗: 8weeks
• Western Ontario MacMaster University Osteoarthritis Index (WOMAC)
时间窗: 8weeks
• Radiological evolution assessed by Joint space narrowing
时间窗: 8weeks
次要结局
- Haematological and biochemical assessments for safety