A Clinical Study to Evaluate the Safety and Therapeutic Efficacy of Safuf-e-Chobchini in the Management of Waja-al-Mafasil (Rheumatoid Arthritis); A Block Randomised,Open label,Standard Control Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1.Pain intensity
研究概览
简要总结
Rheumatoid arthritis is a chronic, systemic inflammatory disease of unknown etiology that primarily targets synovial tissue.Rheumatoid arthritis is a global disease with a variable geographic prevalence of 0.5% to 1% adults.The incidence of rheumatoid arthritis increases between 25 and 55 years of age, after which it plateaus until the age of 75 and then decreases.The disease may be insidious in nature rarely occurring in men younger than 30 years with gradually rising incidence with advancing age. In women the incidence steadily increases from mid 20s to peak incidence between 45 to 75 years. Rheumatoid arthritis occurs more commonly in females than in males, with a 2-3:1 ratio.
It has been recognised that genetic factors contribute to occurrence of rheumatoid arthritis.Increasing evidence supports a substantial role for environmental factors including smoking,other pulmonary exposures (silica), obesity, vitamin D deficiency as enhancing factors for rheumatoid arthritis risk.
The primary target tissue is the inflamed synovium that contains a range of activated leucocytes and stromal cells that under the influence of inflammatory cytokines drive local cartilage and bone destruction. Patient often complains of early morning joint stiffness lasting more than 1 hour that eases with physical activity.The earliest involved joints are typically the small joints of the hands and feet.
In Unani system of medicine, Rheumatoid arthritis comes under the heading of “Waja-al-Mufasil†and “ghatiyaâ€.The cause of this disease is believed to be derangement of temperament (soo-e-mizaj.The management of rheumatoid arthritis has continued to improve globally, where early use of conventional and biologic disease modifying antirheumatic drugs (DMARDs) have dramatically improved patient outcome ;however ,a sizeable proportion of patients do not respond adequately to treatment. In addition, these powerful drugs are often associated with unpleasant side effects and occasionally serious adverse events. Furthermost ,the high cost of biological drugs has hindered their accessibility .For these reasons rheumatoid arthritis patients are increasingly seeking complimentary and alternative medicinesâ¶.The unani formulation Sufuf-eChobchini is a unani pharmacopeial formulation commonly prescribed for waja’almufasil(arthritis).It contains eight herbal drugs namely Ushba-e-Maghrabi (Smilax aristolochifolia),Chobchini (Smilax china L.),Gul-e surkh(Rosa damascena Mill.),Barg-e sana (Cassia angustifolia Vahl),Suranjan Sheeren (Merendra persica), Sandal sufaid (Santalum album L.),Bisfaij fistaqui (Polypodium vulgare),Aftimoon (Cuscuta reflexa Roxb.).
These ingredients are reported to have anti inflammatory, analgesic,phelgemogue and purgative activities . Even though this formulation has been used in the unani system of medicine for years,its efficacy in rheumatoid arthritis has not been validated using modern scientific parameters
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
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients in the age group of 18 to 65 years.
- •2.Patients irrespective of gender.
- •3.Patients who fulfill the criteria of the New American College of Rheumatology European League Against Rheumatism 2010 for the diagnosis of rheumatoid arthritis.
- •Patients, who are ready to sign the informed consent, follow the protocol and willing to participate in the clinical study voluntarily.
排除标准
- •1.Women who are pregnant, planning pregnancy, or breast feeding.
- •2.Patients with systemic,extra-articular manifestations of rheumatoid arthritis.
- •3.Patients having gouty arthritis and psoriatic arthritis.
- •4.Patients with history of systemic disease like uncontrolled diabetes mellitus and hypertension,hepatic dysfunction and impaired renal function.
- •5.Patients currently receiving or have received intra-articular treatment, oral or parenteral corticosteroids, or NSAIDs within 2 weeks, DMARDs or anticipated IFN therapy within 4 weeks prior to study entry.
- •6.Obese subjects with BMI ≥35.
结局指标
主要结局
1.Pain intensity
时间窗: Day 0,Day 14, Day 28,Day 42
2. Joint swelling
时间窗: Day 0,Day 14, Day 28,Day 42
3. Morning stiffness
时间窗: Day 0,Day 14, Day 28,Day 42
4. Fatigue
时间窗: Day 0,Day 14, Day 28,Day 42
5. Restricted movement of joints
时间窗: Day 0,Day 14, Day 28,Day 42
6. Joint tenderness
时间窗: Day 0,Day 14, Day 28,Day 42
次要结局
- 1.DAS 28(2.HAQ disability index score)
研究者
Dr Zaffar Hussain
Regional Research Institute of Unani Medicine (RRIUM) , Srinagar
