A Clinical Study to evaluate the efficacy of the Munzij Mushil therapy along with Coded Unani Drugs UNIM318 and UNIM319 and dry fomentation in patients of Primary Tahajjur-e-mafasil called as Osteo Arthritis Grade I and II.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in sign and symptoms such as joint pain, swelling, difficulty in movement. Improvement in biochemical indices such as S. uric acid and CRP.
研究概览
简要总结
A clinical study is planned to evaluate the efficacy and safety of the Munzij, Mushil and Tabreed therapy along with Coded Unani Drugs UNIM-318 and UNIM-319 and dry fomentation in patient of Tahajjur-e-Mafasil known as primary osteo-arthritisGrade I and II. The protocol of the study has been approved by the IEC of CRIM Lucknow. A total number of 60 patient will be recruited in the study and will receive the Unani regimen as mentioned above for 119 days. The efficacy will be assessed based on improvement in joint pain, swelling and difficulty in movement for which VAS score will be employed. The safety of the regimen will be assessed based on the changes in biochemical and hematological indices. The study will help establish relatively safe and effective Unani regimen for the treatment of osteo-arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •With or without overweight BMI 30 With clinical signs and symptoms pain swelling tenderness stiffness 30 minutes and creaking in knee joints if knees involved 4 Positive findings in Osteoarthritis Grade I and II by Radiology 5 ESR40 mm hr C reactive protein 10 mg l will be considered for inclusion in the study 6 Patient agrees to remain in study with assured co-operation in all respects till completion of the study.
排除标准
- •1 R A systemic joint diseases or any other type of arthritis 2 Pregnancy lactating woman 3 Hypertension and other cardiovascular diseases 4 Diabetes and other metabolic disorders 5 Tuberculosis and other respiratory diseases 6 Gastrointestinal bypass surgery including irritable bowel syndrome 7 Renal hepatic impairment 8 History of presence of malignancy 9 History of alcohol and drug abuse 10 Epilepsy and other neurological disorders 11 Patient receiving treatment with experimental drugs within a 30 days prior to the study 12 Intra articular treatment Such that Corticosteroid or hyaluronic acid or treatment with medicine for O A in previous 3 months such that Glucosamine sulphate Chondroitin sulphate Diacerine etc 13 Arhroscopy or any knee surgery in the previous 6 months 14 Treatment with anticoagulant or history of haemophilia 15 ESR 40mm hr and CRP level 10 mg L.
结局指标
主要结局
Improvement in sign and symptoms such as joint pain, swelling, difficulty in movement. Improvement in biochemical indices such as S. uric acid and CRP.
时间窗: 119 days
次要结局
- No significant changes in hematological & biochemical indices such as CBC LFT & KFT ensuring safety of the regimen(At baseline 30 days 60 days & 90 days)